This week, Phispers has lots of interesting pharma news from the across the world, including an analyst’s take on why Pfizer should not split, Elder Pharma’s COO being caught bribing a government official and how Teva’s entry into PhRMA is being resented by other players. And, don’t miss the news on next-generation women who are changing the face of pharma and healthcare in India. GSK’s uses Apple’s ResearchKit, while Roche and Valeant face problems with clinical trials When it comes to clinical trials, this was certainly a week
of action. First, Swiss drug maker Roche reported that a late-stage clinical trial showed its new blood cancer drug – Gazyva – failed to deliver significant improvements over its older Rituxan
medicine. And then there was news regarding suicide risks linked to an experimental
Valeant
Pharmaceuticals drug used to treat psoriasis. The US Food and Drug Administration (FDA)
reviewers raised concern over
the suicide risk. This news followed similar news about the FDA
allowing
Juno Therapeutics to resume its clinical trial after the death of three patients.When it comes to clinical trials there was some exciting
news from GlaxoSmithKline
last week. GSK announced it is taking the next-generation approach to clinical trials by initiating a study on rheumatoid arthritis using Apple’s ResearchKit.
This is the first time a drug maker is using the health system for the iPhone
to conduct clinical research.GSK intends to record the mobility
of 300 participants over three months. The company will also ask these
patients to input both physical and emotional symptoms, such as pain and mood. The application created by GSK using ResearchKit comes with a guided wrist exercise that uses the phone’s sensors to record motion. This gives the drug company a standardized measurement across all users. The company will use the results to help design better clinical trials. GSK’s bulk drug plant in UK receives FDA’s warning letter for making contaminated drugs While still on GSK, there was some bad news too for the
British drug maker. FDA investigators at GSK’s API manufacturing facility in Worthing, UK, found penicillin
in non-penicillin manufacturing areas approximately 69 times in 2012, 72 times
in 2013, 30 times in 2014, and 16 times through July 7, 2015.Contamination of non-beta-lactam drugs with beta-lactam
drugs (such as penicillin) presents great risks to patient safety, including
anaphylaxis and death. There is no safe level of penicillin contamination, as
no level has been determined to be tolerable risk.As a follow up to the FDA inspection, GSK had to recall
various lots of Bactroban® (mupirocin calcium) products due to potential contamination with penicillin and foreign substances such as glass, paint fragments, and fibers.This is not the first time a facility has had manufacturing compliance issues. In late 2015, a European regulatory body suspended marketing of its drug – Zantac – across Europe for not dealing with a decade-old problem of manufacturing the drug at this facility. To split or not to split – that may no longer be the question before PfizerThere has been a lot of talk around Pfizer executives indicating that the American pharmaceutical bigwig may be split into different companies in order to bolster
shareholder value. This talk gathered momentum three months back, when it
scrapped the US $ 160 billion deal to acquire Allergan.However, the idea to split Pfizer was floated five years ago. It was intended to create two different companies – one would produce older drugs, while the other would focus on newer medicines. While a decision on splitting Pfizer is likely to be taken
later this year, one Wall Street analyst questioned whether the big drug maker should
actually be split. In a note to investors, Sanford
Bernstein analyst Tim Anderson suggested a split may not unlock “substantial additional” value for shareholders. Anderson forecasts a value of about US $ 36 a share, which
is roughly in line with the current stock price. And unlike in 2011, when
growth prospects seemed fuzzy, Pfizer seems to be in a better position today. Competitors resent Teva’s entry into trade associationTeva – the world’s largest generics player – was made a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) last week. The trade association announced it had admitted
Teva along with rare-disease manufacturer Alexion
and specialty pharma Jazz.
AMAG
Pharmaceuticals and Horizon
Pharma also became full members, transitioning from research
associates.However, Teva’s peers are not exactly happy that the Israeli drug maker has joined their exclusive club. For instance, AbbVie argued against letting the copycat giant in. AbbVie claimed that by admitting Teva into PhRMA, the association would dilute its “emphasis on innovation” and spur “internal conflicts” between Teva and companies whose patents it seeks to invalidate.Apart
from being a top generics player, Teva is also into branded sales, thanks to multiple
sclerosis blockbuster drug Copaxone,
and to a lesser extent, the brands it acquired in its Cephalon
buyout. Teva had acquired the generics business of Allergan last year for US $ 40.5 billion. As a result, it is selling generic brands in the United States and Europe. In fact, all generic majors – including Dr. Reddy’s, Impax,
Mayne, Zydus Cadila,
Aurobindo,
Intas
and Torrent – have queued
up to acquire a band of products put on the block by Teva in Europe. FDA puts four companies that didn’t pay GDUFA fee on import alert. Over the last two years, companies like China’s Jiangsu
ZW Pharmaceuticals and Wuxi
Kaili Pharmaceutical Company, and India-based Fleming
Laboratories and Sharon
Bio-Medicine had received warning letters from the
FDA for failing to pay the GDUFA (Generic Drug User Fee Amendments) fees.This week, for the first time, the FDA used the authority provided by the Congress to enforce GDUFA’s user fee provisions and placed these firms on import
alerts. The FDA added the four companies (mentioned above) to a list
of generic drug facilities that are banned
from shipping products to the US since they have not paid the GDUFA fee and
have failed to meet identification requirements stipulated in the GDUFA of
2012. Next-generation women
in Indian pharma and healthcareIndia’s pharmaceutical and healthcare industry has traditionally been a male bastion. This is true of many other countries as well. However, according to a news
report published this week, a big change is sweeping across this immensely
technical and challenging business landscape. And a new crop of business
leaders has emerged in India that is coming up with game-changing ideas. “These women have added tremendous value in shaping these organisations,” says the news report.The story profiled five next-generation women – Namita Thapar (39), CFO of Emcure
Pharmaceuticals, Zahabiya Khorakiwala (33), Managing Director of Wockhardt
Hospitals, Tara Singh Vachani (29), CEO and Managing Director of Antara Senior
Living, Ameera Shah (36), Managing Director of Metropolis Labs and Samina
Vaziralli (37), Executive Director of Cipla. Elder Pharma’s COO bribes government official for preventing SFIO probeWhile the next-generation women are busy adding value to
their pharma business, another next-generation promoter of a pharma company was
indicted for bribing a government official.
Last week, the Central Bureau of Investigation arrested
a senior Ministry of Corporate Affairs (MCA) officer – B K Bansal – in Delhi for allegedly taking a bribe of Rs 9 lakh from Anuj Saxena, COO of Elder
Pharma, through a middleman for preventing a Serious Frauds Investigation
Office (SFIO) investigation pending against the company.Bansal was director general of MCA. At first, Bansal
demanded Rs 50 lakh, but later settled for Rs 20 lakh to prevent the investigation.
He was caught accepting the second tranche of the payment. Elder Pharma has been going through a crisis recently, after
the MCA red-flagged several discrepancies in its finances. The company had only
recently sold a major stake in the company. India’s pharma exports to US, Europe decline by 7 percent in Q1Over the last several months, we have been reading a lot of
news regarding compliance issues being faced by Indian pharma companies. Well,
all those compliance issues have begun to have a bearing on the financials of
Indian pharmaceutical companies. According to figures released by the Pharmaceuticals Export
Promotion Council (Pharmexcil),
the exports of Indian pharmaceuticals to Europe and the US witnessed a negative
growth of 6 to 7 per cent in the April to June quarter this year.Pharmexil will organise an interactive meeting with the joint
secretary of the Department of Commerce (DoC) to discuss the reasons behind this
decline in exports.Says P V Appaji, director general of Pharmexcil: “Though the Indian pharma exports performed well last year, we have seen a decline in pharma exports, particularly to the US market, in last three months.”
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