Pharma News
Home  »  Community News  »  Pharma News
Dec
4
Sandeep Singh Dhillon
Brexit impact on UK pharma industry to be investigated – BBC News
Pharma News, Pharma Notables
0
, , ,

By Bill Wilson
Business reporter, BBC News

Brexit may affect the cost of medicines and hit UK pharmaceutical investment, a Commons committee head has warned.
Rachel Reeves, who chairs the Business, Energy and Industrial Strategy (BEIS) committee, says access to new medical products may also be at risk.
She said the uncertainty around Brexit was “very concerning”, as MPs prepare to examine its effects on the industry.
They include the sector’s access to highly skilled workers after the UK leaves the European Union.
Ms Reeves said the evidence MPs had received suggested Brexit could threaten “the cost of medicines, investment in the UK and access to new and innovative research and products”.
“There are serious concerns raised around the future regulation of pharmaceuticals, mutual recognition of medicines, and the prospect of damaging disruption to cross-EU drug supply chains,” she said.
“This is very concerning, with uncertainty risking the UK becoming a less desirable place for investment and development in a growing, productive industry.
“We are keen to examine the detail of these concerns and to hear from the industry what it wants from the government to ensure the smoothest possible transition as we leave the EU.”
Brexit will mean the relocation of the European Medicines Agency from London to Amsterdam.
The MPs’ inquiry comes despite the announcement last week of two big deals in the UK’s pharma sector.
The government said then that the decisions by MSD, known as Merck in North America, and Germany’s Qiagen illustrated confidence in its recently announced industrial strategy for when the UK leaves the EU.
The industrial strategy white paper outlines the government’s plans to support more research and development, encourage firms to embrace new technology and boost the economy.
A report in the Sunday Times said more major investment for the sector is due to be announced soon, with GlaxoSmithKline expected to reveal a new research partnership.
The Business committee has been seeking views from across the sector and has received written submissions from big pharmaceutical companies, trade unions, industry bodies and the government.
The submissions have been published ahead of a public evidence session on Tuesday when the committee will question witnesses from the industry on the impact of Brexit.
It will consider different outcomes relating to future cross-border customs and trading arrangements, and consider what the government should aim to achieve in negotiations.
Those appearing before the committee will include the Association of the British Pharmaceutical Industry (APBI) and Belgian-headquartered Janssen Pharmaceutical, part of US giant Johnson & Johnson.
The ABPI said the inquiry was important.
“The written evidence received by the committee highlights how regulatory cooperation, a frictionless system for trade and access to research funding, collaboration and talent, underpin the successful development and delivery of medicines,” a spokesperson said.
“Evidence also shows that 45 million packs of medicines go from Britain to the EU every month and 37 million come the other way. With this whole system at stake, clarity on medicines regulation and trade is urgently required for all patients across Europe.”

Full article at http://www.bbc.com/news/business-42213937

Nov
29
Sandeep Singh Dhillon
AstraZeneca and Chinese Future Industry Investment Fund establish joint venture to develop new medicines in China
Pharma News
0
, ,

AstraZeneca today announced a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally, and to bring innovative new medicines to patients in China faster. FIIF is managed by the SDIC Fund Management Company (SDIC Fund), a private equity management company.

The new company, Dizal Pharmaceutical, incorporates all scientific and technical capabilities of AstraZeneca’s Innovation Center China (ICC), and holds exclusive rights to develop and commercialise three potential medicines currently in pre-clinical development from AstraZeneca’s pipeline in its main therapy areas of oncology, cardiovascular and metabolic diseases, and respiratory. It is also expected to initiate novel clinical programmes. The FIIF will contribute funding and expertise in establishing strategic partnerships in China.

Dr. Xiaolin Zhang, previously Head of AstraZeneca’s ICC, has been named as Chief Executive Officer of the new company. All staff employed by the ICC have been invited to join the new company.

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “AstraZeneca has a long-standing and strong commitment to China, which we are reinforcing today with this ground-breaking joint venture. By joining forces with the FIIF, we aim to accelerate the local discovery and development of innovative, affordable medicines for patients in China and around the world.”

Guohua Gao, Chairman of SDIC Fund, said: “FIIF is delighted to be collaborating with AstraZeneca to promote the development of innovative medicines. AstraZeneca’s Innovation Center China has an excellent track record of drug discovery, and the synergy created by combining AstraZeneca’s scientific talent and assets with FIIF’s China expertise and funding will help further promote innovation in medical science.”

The remit of the FIIF in the pharmaceutical industry is to promote the development and manufacturing of innovative medicines in China through strategic partnerships. The joint venture supports AstraZeneca’s commitment to enhancing China’s research and development capabilities through diversified external partnerships that deliver value to patients in China.

SDIC Fund Management Company (SDIC Fund) is an independent private equity fund manager established in August 2009. It currently advises and manages more than RMB 60 billion of capital. The Future Industry Investment Fund is one of the funds that are managed by SDIC Fund. The limited partners of SDIC Fund include a wide range of institutional investors across China. The core strategy of SDIC Fund is to invest in market leading companies with attractive growth prospects and outstanding management teams. In partnership with the portfolio companies and their management teams, it aims to contribute strategically and add business value to the companies. SDIC Fund prides itself on its ability to forge effective and mutually rewarding partnerships with exceptional management teams to execute its strategy of investing in quality businesses, and adding value to make them grow to become leaders in their respective industry. SDIC Fund’s primary focus in China includes healthcare, advanced manufacturing, TMT and environmental protection.

About AstraZeneca in China

Since entering China in 1993, AstraZeneca has been committed to continuously following the science, focusing on innovation and becoming one of the most trusted healthcare partners to bring high quality, innovative medicines and complete disease solutions to Chinese patients from disease prevention to diagnosis, treatment and rehabilitation. We develop long-term partnerships with Government, academia and local scientists across research and development (R&D) and manufacturing.

AstraZeneca has end-to-end R&D capabilities in China, from discovery to clinical development and manufacturing of innovative medicines. Our comprehensive presence includes manufacturing sites in Wuxi and Taizhou and a China Distribution Centre in Wuxi. AstraZeneca’s China headquarters are based in Shanghai and the company has more than 11,000 employees throughout the country.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Full article is available at http://www.worldpharmanews.com/astrazeneca/4208-astrazeneca-and-chinese-future-industry-investment-fund-establish-joint-venture-to-develop-new-medicines-in-china

Nov
27
Sandeep Singh Dhillon
Roche Cancer Drug Rises To Challenge Merck, Bristol-Myers – Forbes
Pharma News, Pharma Notables
0
, ,

By Matthew Herper

Tecentriq, a cancer immunotherapy developed by the Swiss drug giant Roche, slowed the progression of previously untreated lung cancer in a large clinical trial when combined with a chemotherapy regimen, the drug giant said.

“We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer said in a press release

The news represents the latest upset among a class of new medicines that unlock the body’s ability to fight tumors. These medicines, called PD-1 inhibitors, are already big sellers for Bristol-Myers Squibb and Merck. In the third quarter of 2017, Bristol’s Opdivo generated $1.3 billion in sales; Merck’s Keytruda generated $1 billion. Financial analysts at Wall Street banks forecast that by 2022, these drugs will generate annual global sales of $25 billion a year, with the bulk of sales going to Bristol and Merck.

Merck has pulled ahead of Bristol, the pioneer in developing these drugs, because an early Merck trial in first-line lung cancer succeeded, while a similar study from Bristol failed, baffling investors and researchers. Keytruda is approved in advanced non-small lung cancer in patients whose tumors express a protein called PD-L1 above a certain level, or in combination with the chemotherapy drugs Alimta and carboplatin. Today’s Roche result complicates things further, because Roche used a different combination of drugs

Roche’s study had three arms. All patients received carboplatin and paclitaxel, the cancer drug once sold as Taxol. The control group also received Avastin, one of Roche’s best-selling cancer drugs. Then two groups got Tecentriq, one with Avastin and one without. What Roche has announced today is that the Avastin-Tecentriq-chemotherapy combination did better than Avastin and chemotherapy alone, and that the survival results so far are “encouraging.” That leaves a big question: how are the patients who got Tecentriq, but not Avastin, doing?

It’s impossible to know exactly what this will mean until the full results of the study are presented. (Companies release early results by press release because they are considered too important to investors to keep secret.) In morning trading, Roche shares are up as much as 5.6%, and Merck shares are down 2%. But two analysts, Umer Raffat of Evercore/ISI and Timothy Anderson at Bernstein Research. commented that the results could actually be seen as a validation of the general Merck approach of combining PD-1 drugs with chemotherapy. Rivals, including Bristol and AstraZeneca, have favored combining them with another type of immunotherapy drug, called a CTLA4 inhibitor, such as Bristol’s Yervoy.

One big question will be how the chemotherapy regimens stack up against the CTLA4 combinations. Another will be how they stack up against each other. How will doctors compare the Merck and Roche drug regimens? How will insurance companies decide which ones to cover? Anderson, the Bernstein analyst, said that investors are likely to not view Roche as a big threat because it is entering the market late. But he also wrote that the trial is “one important piece of a complex, still largely incomplete, puzzle.” Bernstein forecasts 2022 Tecentriq sales of $3.7 billion, less than half as much as for Opdivo or Keytruda.

Nov
24
Sandeep Singh Dhillon
Teva Pharmaceutical Set for Major Layoffs in Israel, U.S. – Reuters
Pharma News, Pharma Notables
0
,

Teva Pharmaceutical is expected to cut up to a quarter of its 6,860-strong workforce in Israel, and a few thousand more staff in the United States, media reported Thursday, though a minister said the figures may not be accurate.

The world’s largest generic drugmaker will send termination letters to “tens of percent” of its 10,000 employees in the United States in coming weeks, Israeli financial news website Calcalist said, citing people familiar with the matter.

The debt-laden company’s stock closed up 4.6 percent in Tel Aviv on the report. A spokesman for Teva, which was seen as one of Israel’s great corporate success stories, declined to comment.

Teva had been widely expected to cut costs after warning this month it would miss 2017 profit forecasts due to falling prices of generics in the U.S. and weakening sales of its multiple sclerosis drug Copaxone.

Teva has also been saddled with nearly $35 billion in debt due to its $40.5-billion acquisition of Allergan’s generic drug business Actavis last year. Investors have been pushing for clarity on its future.

Teva has already been selling off assets to help meet its debt payments.

Teva’s new Chief Executive Kare Schultz was working out the details of the job cuts with regional management in Israel and the United States, Calcalist reported.

It said between 20-25 percent of the staff in Israel could go, including Michael Hayden, Teva’s chief scientific officer and president of research and development.

Israeli Economy Minister Eli Cohen told Reuters he had spoken with officials at Teva and was told that the numbers leaked to the media were off.

“I spoke to them this morning, they said the figures are not accurate,” Cohen said.

The Histadrut labour federation said it would not accept any unilateral moves by Teva’s management.

“Any efficiency measures, if and when they arise, will be done through negotiations and with the agreement of the Histadrut and the labour unions,” Histadrut spokesman Yaniv Levi said. “Lay-offs are the last resort.”

Fitch Ratings downgraded Teva’s debt to junk this month. (Editing by Andrew Heavens)

Read more: Teva Pharmaceutical Set for Major Layoffs in Israel, U.S. -Report | Investopedia https://www.investopedia.com/partner/reuters/teva-pharmaceutical-set-major-layoffs-israel-us-report/#ixzz4zMQtBcMy
Follow us: Investopedia on Facebook

Nov
3
Sandeep Singh Dhillon
Amazon should buy these companies if it wants to get into selling drugs – CNBC News
Pharma Extra, Pharma News
0
,

Christina Farr | @chrissyfarr

Amazon is considering getting into the business of selling prescriptions online.
CNBC asked five experts to pick the company that Amazon should buy first to help it compete in the $560 billion market.

Amazon should buy these companies if it wants to get into selling drugs, say experts Amazon should buy these companies if it wants to get into selling drugs, say experts. Amazon is already in a range of businesses that touch on the multitrillion medical sector, including selling surgical equipment and supplies, as well as its cloud software services which many big health-care companies use.

But if it wants to get into selling prescriptions, it might speed its time to market by making a buy-up of a company already in the space. There’s a precedent in Amazon’s $13.7 billion acquisition of grocery store chain Whole Foods earlier this year. Amazon has about $13 billion in cash and equivalents, as of September of this year.

So we asked 5 experts for their predictions on the companies that Amazon might look to acquire if it decides to move ahead with becoming an online pharmacy. Their answers have been edited for brevity.

Prediction: Premier

Scott Barclay, partner at venture fund DCVC and former vice president at e-prescription software provider Surescripts.

What is it? A group purchasing organization created to allow hospitals and other providers to pool their purchasing power to secure discounts on medical and other hospital supplies.

Why? According to Barclay, it’s a no-brainer for Amazon to buy a group purchasing organization or “GPO.” And Premier is the largest in the U.S., with a network of more than 3,750 U.S. hospitals and 130,000 other providers.

What’s in it for Amazon? “It’s a low-cost way to break into the (drug) supply chain that touches a large chunk of health care GDP,” Barclay said. “Amazon would quickly create a multibillion-dollar business without fundamentally taking on much risk or even being very innovative.”

Another benefit, according to Barclay, is that it buys Amazon time. It could pick and choose if it wants to go after more challenging opportunities like data and informatics, care provision and health insurance.

Any cons? Premier, which went public in 2013, wouldn’t come cheap — it’s currently got a market cap over $4 billion, and revenue jumped 15 percent to $1.16 billion in fiscal 2016. It has also been on a buying spree of its own of late to strengthen its market position.

Prediction: Express Scripts

Dr. Mark Frisse, Department of Biomedical Informatics at Vanderbilt University Medical Center and former chief medical officer at Express Scripts.

What is it? Express Scripts is the largest pharmacy benefits manager in the United States. These companies, known as PBMs, act as intermediaries between payers, like health insurers, and the rest of the health system.

Why? The culture fit. Amazon and ExpressScripts have a lot in common, according to Frisse. “These companies have the same business acumen, market discipline, and mastery of logistics and delivery.”

ExpressScripts could take on a job that Amazon might want to avoid, suggests Frisse. “Its team brings to the table the capabilities of managing a Byzantine and arcane process of pharmacy regulation,” he said. As Express Scripts CEO Tim Wentworth told analysts in July, it’s far more complicated than just dispensing drugs. Entering the business, “requires you to figure out how not to dispense drugs or to dispense the right drugs as much as it does to dispense them.”

Why not? It would be a massive purchase — Express Scripts has a market cap of more than $35 billion, more than twice the price Amazon paid for Whole Foods, and the company would have to borrow to take that on. It might be an easier option for Amazon to buy a small or midsized pharmacy benefits manager at a lower price, and still gain the national footprint and regulatory expertise.

Prediction: Glooko

Nina Kjellson, Canaan Partners’ biotech and health IT investor (note: Glooko is a Canaan portfolio company).

What is it? Glooko is a subscription-based diabetes management web and mobile app for patients and their health providers. It claims to have millions of users worldwide.

Why? Kjellson sees Amazon having a big impact in public health, especially in areas like obesity and diabetes. With Amazon already starting to sell medical supplies online, Kjellson sees the company carving out a big business in diabetes prescription medications and glucose meters/ strips, which is a $70 billion market and growing. “So Amazon should pick up a diabetes management platform like Glooko to have a consumer and health-care solution that ties the entire disease management ecosystem together in a great, consumer experience.”

Another bonus? As Amazon gets into the grocery business in the wake of its Whole Foods buy-up, it could consider personalized meal recommendations — a benefit for millions of people managing chronic conditions like Type 2 diabetes.

Why not? Privacy. Amazon already knows so much about its customers through their buying habits. Some users might be uncomfortable sharing their health status. Moreover, managing populations with chronic diseases is not Amazon’s core competency.

Prediction: GoodRX

Annie Lamont, managing partner at investment firm Oak HC/FT.

What is it? GoodRx offer coupons that consumers can take to the pharmacy to get discounts on prescription drugs. It claims to have lower prices than what a consumer would otherwise pay out of pocket.

Why? “It’s the most successful consumer-facing app for prescription drugs that is focused on comparing and giving the consumer the lowest cost,” said Lamont. And that’s an ideal fit for Amazon, which prides itself on transparency. GoodRx founder Doug Hirsch has also publicly stated that he would welcome Amazon’s long-rumored entry into the space.

Why not? “Valuation,” suggests Lamont. GoodRx hasn’t raised much in funding — $1.5 million in seed financing and an additional follow-on sum that hasn’t been disclosed — but has grown quickly since its 2012 launch and established itself as one of the biggest players in the space.

Any big risks? GoodRx has contracts with pharmacy benefits managers and retailers behind the scenes, explains Lamont. So there’s always a risk that they pull out, if they’re feeling threatened by Amazon.

Prediction: PillPack

Stephen Buck, co-founder of cancer-advisory site Courage Health and co-founder of GoodRx.

What is it? Pillpack is an online pharmacy start-up that delivers prescriptions by mail in personalized packets, based on when the user needs to take them.

Why? If Amazon got into the business of selling prescription drugs, PillPack seems like an obvious pick to Buck. “It’s a direct-to-consumer company that would fit nicely into Amazon’s Prime delivery service,” he said.

A good deal: PillPack also isn’t encumbered by a large retail operation, Buck said, meaning it doesn’t have a huge network of brick-and-mortar pharmacies. For that reason, it might also be “relatively cheap to buy,” he suggests, despite that it has raised more than $117 million in financing from venture investors to date.

Why not? The product might be too niche for Amazon, suggests Buck. “The whole experience including the packaging might only appeal to a certain segment of people who take multiple medications.”

Read full article here https://www.cnbc.com/2017/11/02/amazon-pharmaceutical-move-acquisition-targets.html?lipi=urn%3Ali%3Apage%3Ad_flagship3_feed%3B%2BaGvcVckQQi8j8AOTm8tcg%3D%3D

Nov
3
Sandeep Singh Dhillon
Torrent may announce Unichem’s domestic business buy today – Economic Times India
Pharma News
0
, ,

MUMBAI: India’s oldest drug maker Unichem has finally found a suitable buyer for its domestic formulations business in Torrent Pharma, ending more than a decade of speculation over the company’s future.

Torrent is likely to announce the acquisition on Friday for a total consideration of Rs 3,250 crore, making the Ahmedabad-based drug maker among the top five drug firms in the domestic market, said multiple sources aware of the matter. Both companies have their board meetings scheduled in Mumbai for Friday. The deal includes some of the manufacturing units and employees.

The domestic portfolio, especially its Losar brand of cardiovascular drugs, is believed to be of great interest to the acquirers. Market share of the Losar brand of drugs, used in the treatment of high blood pressure, improved by 4.8% in FY17 and maintained its top rank, Unichem had said in its investor presentation on May 30.

Torrent and Unichem did not respond to an email query sent by ET. In a recent conference call on July 31, Sanjay Gupta, executive director (international business) of Torrent Pharma, had said that the company continues to explore acquisition opportunities in India.

Unichem promoted by pharma industry veteran Prakash Amrut Mody recorded domestic sales worth Rs 976 crore in the past ten months, with a 5% growth. Mody and his wife Anita Prakash jointly own 80% stake in the company that has a market cap of Rs 1,415 crore as on Thursday’s market closing.

Sources told ET that succession issues, coupled with a slowing growth due to price cuts had impacted Unichem, leading to its decision to sell its domestic business. Unichem has been in play for years with global players such as Abbott India and Mylan Laboratories. More recently, PE firm Advent was in advance negotiations with the Unichem management to buy them out, but the deal fell through after Torrent entered the fray. ET had reported about Unichem’s plans to sell its domestic business in 2015.

The Unichem stock has rallied 24% in the past one month in anticipation of the deal. The shares of the company ended the day on Thursday at Rs 311.45, down 1.8%, on the BSE.

RENEWED FOCUS
During FY2012-FY2015, Unichem restructured its domestic business and added five new divisions to maintain a product and therapy-specific approach. Unichem’s key focus is on brand building, with four of its products finding a place in the top 300 brands in the Indian Pharmaceuticals Market (IPM).

The company maintains a balance between the chronic segment (59% of December 2016 sales in India) and the acute segment (41% of December 2016 sales in India). It has also sharpened its focus on chronic therapies, resulting in high profitability and rapid growth. To overcome the price cuts suffered from NLEM, Unichem has added new products in its portfolio and also been investing in the antidiabetic segment — a regular and highly profitable business segment — with a sharper focus.

During Q2FY2017, Unichem also entered the OTC segment by launching Unienzyme for the treatment of gastritis. That alone is a strong Rs 50-60 crore brand with no direct competition. But, it has a limited market presence. The company also planned to tie up with innovator companies for the upcoming molecules in the anti-diabetic segment. It could launch some other gastro products through the OTC route in the next 2-3 years.

“We are positive about Unichem’s long-term business prospects, and expect 15% and 29% revenue and adjusted PAT CAGRs respectively, over FY17-19. We expect the company’s domestic formulations to recover gradually and expect traction in its export formulations,” said Rashmi Sancheti, analyst with Anand Rathi, in a report earlier this June.

For Sudhir and Sameer Mehta, the promoter brothers of Torrent group, this acquisition is a sign of the company’s plans to be a domestic conglomerate. Besides interest in power, Torrent has been on an aggressive shopping spree in India.

Read more at:
//economictimes.indiatimes.com/articleshow/61472060.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

Oct
13
Sandeep Singh Dhillon
NIH And 11 Pharmaceutical Companies Announce $215 Million Collaboration – Forbes
Pharma Extra, Pharma News
0
, , , ,

By Ellie Kincaid , FORBES STAFF

The U.S. National Institutes of Health and 11 pharmaceutical companies today announced the launch of a five-year cancer immunotherapy research collaboration as part of the Cancer Moonshot. In total the partners will contribute $215 million to what they are calling the Partnership for Accelerating Cancer Therapies (PACT).

PACT’s fundamental question, NIH director Francis Collins told reporters in a press conference, is, “why doesn’t immunotherapy work for all patients in all types of cancer, and what can we do about that?”

Top priority in answering that question is testing immune- and cancer-related biomarkers in clinical trials to understand the mechanisms of how cancers respond to or resist immunotherapy. With standardized biomarkers to look at and harmonized assays to test them across many different trials, data from different studies will be more easily compared, Collins said.

Developing standardized biomarkers for immuno-oncology will be “extremely enabling,” like standardizing IP addresses in the early days of the web, Thomas Hudson, vice president for oncology discovery and early development at AbbVie, said at the press conference.

He expects having standard biomarkers and sharing data will help provide a scientific basis for deciding which cancer drugs to try in combination. Given the sheer number of potential combinations, that’s “one of the key reasons we got involved in PACT,” he said. “We don’t think random combinations are the way to go.”

The data for researching biomarkers will come from four National Cancer Institute-funded Cancer Immune Monitoring and Analysis Centers at Dana-Farber Cancer Institute, Stanford Cancer Institute, Precision Immunology Institute and the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai and University of Texas MD Anderson Cancer Center. The centers will support adult and pediatric immunotherapy trials with tumor and immune profiling.

Getting access to data from clinical trials NCI supports was “very attractive,” Hudson said.

Which biomarkers the collaboration will focus on first is still to be discussed at a meeting the companies will likely have next month, said Douglas Lowy, NCI’s acting director.

The 11 pharmaceutical companies participating are AbbVie, Amgen, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb, Celgene Corporation, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research and Pfizer. Each will contribute up to $1 million per year for the five-year partnership, totaling $55 million.

The NCI will make up the rest with $160 million in funding mostly from the Cancer Moonshot, with some coming from regular appropriations, Lowy said.

Read the full article at https://www.forbes.com/sites/elliekincaid/2017/10/12/nih-and-11-pharmaceutical-companies-announce-215-million-collaboration/#287c1aef7b54

Oct
2
Sandeep Singh Dhillon
Malaysia’s healthcare budget below WHO recommendation – The Malaysian Insight
Pharma News, Pharma Notables
0
, , ,

By Noel Achariam

MALAYSIA’S budget for healthcare is 3% lower than the World Health Organisation (WHO) recommendation and needs to be raised, said a consultant.

InfoMed chief executive officer Mohan Manthiry said the nation’s current budget for healthcare was 4% of the gross domestic product, and the government must spend more to provide quality care especially in public hospitals.

“The general population, where a majority are hard-pressed by inflation, are now flocking to government hospitals.

“Malaysians can’t afford proper healthcare because of stagnant salaries, poor revenues and negative growth.

“The government needs to provide more services, improve facilities and reduce congestion.

“To do this effectively, the government needs to allocate more funds for healthcare,” he said after speaking at the Malaysian Insurance Institute on Medical Health and Insurance Seminar today.

It was reported that the Health Ministry would seek a bigger allocation under Budget 2018 due to increasing medical costs.

Its minister, Dr S. Subramaniam, said the RM23 billion allocated for this year was insufficient, which prompted the ministry’s request for an increased allocation.

He said the ministry was committed to providing the people with quality healthcare.

Budget 2018 will be unveiled in Parliament on October 27. In past budgets, the ministry had received between 10% and 15% more in the annual allocation.

Mohan said according to WHO, the recommended budget for healthcare in Malaysia should be 7%.

“Malaysia’s current budget (for healthcare) is 4% of GDP. Singapore, whose healthcare is among the best in the world, is only spending 5% of its GDP, and is still able to provide quality healthcare.

“This is because the funds have to be efficiently utilised. Otherwise, quality healthcare is not going to be felt by the public.”

Mohan said the healthcare sector should be geared towards prevention and enhancing the education system to reduce incidences of chronic diseases.

“There is a worrying trend in non-communicable diseases, such as diabetes and obesity. This is something we should focus on, which is consuming most of the resources in healthcare. ”

WHO had stated that almost 70% of the global mortality rate was due to such diseases, he said, adding that in Malaysia, the number of patients was on the rise, with the country being No. 1 in diabetes and obesity in the region.

“To manage this, we need to get individuals to take charge. We cannot leave it to the government, doctors and hospitals.

“This has got to do with lifestyle, and one of the major causes is the food we eat.

“We need to have a long-term plan, and I have been advocating the need for education in healthcare.”

Mohan said it was crucial for healthcare to be taught as a subject at the primary school level.

“It should be in the curriculum, where children are taught everything in healthcare and matters related to health, from food and the environment to exercising.

“Such education should start at home, but it’s not happening. So, it has to become part of formal education.

“It is good if this can be implemented in primary schools. Then, the government would not have to spend so much money (in its healthcare budget) because it’s part of the curriculum.”

The original article can be viewed at https://www.themalaysianinsight.com/s/16128/

Sep
20
Sandeep Singh Dhillon
Malaysia moves forward to combat Hepatitis C; issuing compulsory license to produce generic treatment – MIMS Malaysia
Pharma News, Pharma Notables
0
, , ,

By Reshmin Kaur Cheema

With the rising costs of the Hepatitis C treatment, Malaysian authorities have decided to step up and take measures to ease patients’ burden. They will be following through on plans to allow for generic companies to produce a version of the expensive Sovaldi (Sofosbuvir) pill.

This sets Malaysia as the first country to initiate such move, amidst global headlines highlighting this distressing financial matter. In light of the difficulties governments are facing – especially in Malaysia – patient advocates have commended the move in widening access to treatments.

Putting things into perspective, MIMS previously reported that roughly 500,000 or 2.5% of the Malaysian population are said to be living with chronic liver conditions.

Different approach to tackling increased costs

Executive Director of South Centre, a non-governmental organisation based in Switzerland, Martin Khor wrote to The Star publication stating, “The government decision is the key to opening the door to affordable treatment. The government will have freedom to choose which drug to buy from which firm, at what prices, and with which other drugs to combine it.”

This latest update comes after the government initial plans to issue a supposed government-use license that was announced last month. Following this, Gilead Sciences went on to expand a 2014 licensing deal. This allows for seven larger generic drug makers, with operations in India, to sell copycat forms in middle-income countries like Malaysia, Ukraine, Belarus and Thailand.

The deal was originally thought up to increase access in 101 low-income nations and shut down criticism over the pricey drug status. However, Gilead still endured objections because some of those from middle-income countries cannot afford the Sovaldi drug. Thus, the Malaysian government has decided to roll out generic licensing to bypass the Gilead patent altogether.

Consumer activists say that Malaysia chose to pursue the license as a less restrictive option. They elaborated that Gilead’s ways would jeopardise an ongoing Malaysian project whereby the authorities are working hand in hand with Drugs for Neglected Diseases Initiative – a non-profit and an Egyptian company to produce a generic treatment.

Varying responses – to commend or remain sceptical

Sangeeta Shashikant, a legal advisor to Third World Network (TWN), opined that with this move, Malaysia is projected to obtain combination Hepatitis C treatments for USD300 and perhaps less. The Gilead license, on the other hand, may not reflect the most affordable prices, as pricing relies on the level of generic competition in the country.

Consumers Association of Penang stated that “It is imperative that the government sticks to its decision to issue a government-use license. This is because there are strict limits to what Malaysia can do or cannot import or produce under the Gilead license, and other factors that restrict the freedom to choose the generic companies that it can work with.”

It continued, “…Therefore, it is best for Malaysian consumers and patients that the government have both the government-use license as well as the license scheme that Gilead will extend to Malaysia. Both can co-exist, providing Malaysia with maximum policy choice.”

However, The Galen Centre for Health and Social Policy said Putrajaya should deliberate negotiating the best possible deal with Gilead – including technical support, concessions and additional assistance.

Chief executive Azrul Mohd Khalib said, “This hard-won development would see increased access to a treatment which will improve the quality of life for patients and most importantly, save lives. It represents a moral victory for the government which has worked hard to enhance access for Malaysians to innovative drugs and treatment to treat emerging health challenges.”

However, “implementing a government-use license would be outside that framework. It could represent a pyrrhic approach to a long-term problem with possible consequences and complications,” cautioned Azrul. MIMS

Full article at http://today.mims.com/my-moves-forward-to-combat-hepatitis-c-issuing-compulsory-license-to-produce-generic-treatment?elq_mid=35178&elq_cid=26983

Sep
14
Sandeep Singh Dhillon
Faulty EpiPen allegedly linked to unanticipated patient deaths; FDA issued warning letter – MIMS Malaysia
Pharma News
0
,

Tanvi Ambulkar

An EpiPen, which involves administering an emergency injection of adrenaline in the event of life-threatening anaphylactic reactions, is typically used to restore blood pressure and volume. Recently, the makers of EpiPen have come under fire – in view of its failure to properly investigate the complaints that the device misfired during life-threatening emergencies; including several instances, whereby patients later died, according to a warning letter issued by the US Food and Drug Administration (FDA).

Manufacturers failed to conduct comprehensive investigation into complaints received

The FDA alleges that, “Our own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.” Despite these deaths and more than a hundred complaints, no formal inquiry was initiated by the manufacturer. Inspections of the manufacturing process in a Missouri plantation by the FDA in February and March revealed that there were “significant violations” committed in manufacturing the device.

Several EpiPens were recalled by Meridian Medical Technologies, a Pfizer company, in March to prevent retailing defective devices to customers. A FDA spokesperson has issued a statement expressing that the agency “was not aware of defective EpiPens currently on the market.” The FDA had issued a warning letter to Meridian Medical Technologies elaborating on the drawbacks of the production process. The letter detailed that the company had “failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness.”

Responding to complaints – here’s what the manufacturing company has to say…

Pfizer insists that the nature of these complaints is expected because the “product is frequently administered by non-medically trained individuals.” In spite of this, the number of complaints lodged by customers should have elicited some form of inquiry into the quality of the products sold. However, Pfizer furthers claims that there is “no information to indicate that there was any causal connection between these product complaints and any patient deaths.”

Pfizer has been responsible for shipping up to 30 million EpiPens since 2015. Kim Bencker, a spokesperson for the company, echoes the beliefs of the manufacturer by stating that Pfizer was “very confident in the safety and efficacy of EpiPen products being produced at the site.” Whilst it is difficult to establish a direct connection between these products and the deaths, several complaints had been lodged where the device had failed to activate in a crisis situation.

Despite several instances of the device failing to work, the complaints were deemed as insufficiently frequent to act upon. Previous objections expressed by the FDA were also condoned and several devices containing the “potentially defective component” continue to be shipped.

Expensive devices may lead to a fall in sales revenue

As tens of thousands of the products have been recalled by companies, such as Mylan, that uphold “quality and patient safety” – Pfizer would most likely be facing tremendous pressure during these challenging times in overcoming this sales slump. Increasing competition in the market for these devices would also be driving prices to lower rates in order to attract a greater number of customers. MIMS