Market Place
This week, Phispers brings you news from two firms that have bought cast-off drugs from pharma biggies — Axovant and Impact Biomedicines. While the former received two setbacks from its experimental drugs, Impact got bought over by Celgene for its rare blood cancer drug — fedratinib. Meanwhile, India took action against Chinese API firms; the US undertook more measures to speed up approval of generic drugs; and Pfizer shut down its neuroscience research division resulting in loss of 300 jobs.
India takes action against Chinese API firms for failing quality inspections
A special inspection team of the Drug Controller General of India (DCGI) inspected several companies in China recently. Post the inspections, according to a report published in Mint, the DGCI has banned the import of drug ingredients from six Chinese firms due to quality issues.
The ban on the import of active pharmaceutical ingredients (APIs) from China may lead to shortages of antibiotics, anti-diabetes, anti-psychotic and antacid drugs, the report said.
Another news report published in The Economic Times, however, said India has issued show-cause notices to eight Chinese pharmaceutical companies found to be supplying poor quality raw material to drug manufacturers in India. These firms may soon be blacklisted, the report added.
The eight companies are Qilu Tianhe Pharmaceuticals, Hinan Xinxiang Pharmaceuticals, Zhuhai United Labratories, Guangzhao Baiyunshan Pharmaceuticals, Shouguang Fukang Pharmaceuticals, Qilu Antibiotics (Linyi) Pharmaceuticals, Qindao Brightmoon Seawoods and Shanghai Xiandai Hasen(Shangqiu)Pharmaceutical.
India imports about 84 percent of its requirement of APIs. In 2016-17, India imported APIs worth US$ 2.88 billion (Rs 183.7 billion), of which the maximum (66.7 percent) were from China.
According to the Mint report, in its order, the Central Drug Standards control Organization (CDSCO) said the APIs supplied by these Chinese firms may lead to health risks.
FDA begins 2018 with more
initiatives to accelerate generic drug development
The US FDA rang in the New Year with an announcement of additional steps to encourage generic competition as part of its continued implementation of the Drug Competition Action Plan.
The plan has three main components — reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved.
The new steps announced last week intend to achieve the third goal. The FDA released two documents last week that will streamline and improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs). It released a draft guidance for industry – ‘Good ANDA Submission Practices’ – which highlights common, recurring deficiencies in generic drug applications that may lead to a delay in their approval.
The FDA is also taking new steps to enhance the efficiency of its review process. It published a Manual of Policies and Procedures (MAPP) – ‘Good ANDA Assessment Practices’ – which outlines ANDA assessment practices for the FDA staff. According to the FDA, the document formalizes a more streamlined generic review process, including the introduction of new templates that will make each cycle of the review process more efficient and complete.
Celgene to acquire Impact Biomedicines, a startup that bought Sanofi’s cast off drug
Celgene, an American biotechnology firm, agreed to acquire Impact Biomedicines for US$ 7 billion, subject to certain milestones associated with regulatory hurdles and sales performance.
Celgene is interested in Impact Biomedicines’ fedratinib, a kinase inhibitor that has shown promise as a potential treatment for myelofibrosis, a statement said. Myelofibrosis is group of rare cancers of the bone marrow in which the marrow is replaced by scar tissue and is not able to make healthy blood cells.
San Diego-based Impact Biomedicines had bought fedratinib — Sanofi’s cast off drug — in 2013. Fedratinib was a flop for Sanofi as patients began to develop a dangerous neurological condition tied to vitamin B deficiency called Wernicke’s encephalopathy. As a result, the FDA put a clinical hold on it in 2013 and Sanofi ultimately shelved the effort. However, last fall, Impact Biomedicines began convincing regulators that patients can be protected from the lethal side effects of fedratinib.
The US$ 7 billion deal is structured in three parts, with Celgene paying US$ 1.1 billion in cash upfront to Impact Biomedicines. Celgene will pay an additional US$ 1.4 billion on receiving US FDA milestone approvals. Finally, Celgene will make payments depending on sales, with a maximum of US$ 4.5 billion due if annual net sales of Impact’s treatments exceed US$ 5 billion.
While the deal is considered a great buy for drug inventors, and that includes John Hood, one of the co-inventors of fedratinib, analysts say the acquisition may not be great for Celgene. According to a Bloomberg report, Celgene’s shares are “suffering because the company promised investors the world, then significantly revised the planet’s size”. In October 2017, Celgene reported weak third-quarter earnings and significantly cut its ambitious 2020 revenue guidance that it had set in 2015.
Pfizer to cut 300 jobs with the
winding up of its neuroscience research division
American pharmaceutical giant Pfizer Inc’s decision to stop research and development into new neuroscience drugs, including its work in Alzheimer’s and Parkinson’s diseases, will result in around 300 job cuts.
The move to end the neuroscience-discovery program is the result of an internal review, Pfizer said in a statement. The New York-based drugmaker will be cutting jobs at facilities in Cambridge and Andover in Massachusetts, as well as in Groton, Connecticut.
Pfizer has invested heavily in research for Parkinson’s and Alzheimer’s diseases. Along with GlaxoSmithKline, Eli Lilly and several other drug makers, it is part of the Dementia Discovery Fund, a venture capital fund launched in 2015 to develop treatments for Alzheimer’s.
Pfizer said it will continue to support tanezumab, a late-stage pain treatment it is working on along with Eli Lilly, and the fibromyalgia drug Lyrica, as well as continue research into neurological drugs for rare diseases. The company also plans to soon start a venture fund committed to neuroscience.
INC Research-inVentiv Health merged entity finally gets a name — Syneos Health
Back in May last year, INC Research Holdings had announced its merger with private equity-owned inVentiv Health, a fellow contract research services provider. For the last several months, the merged entity has been in existence without a new name.
But last week, INC Research and inVentiv Health were finally reborn as Syneos Health. The merged entity employs over 21,000 persons in clinical and commercial development.
Created by branding agency Addison Whitney, the new name has a deeper meaning — “Syn” represents the value of synchronizing clinical and commercial capabilities offered by the old INC and inVentiv, while “neo” champions a new approach to biopharma solutions.
“Syneos Health fully expresses our value proposition – that is, our ability to deliver integrated end-to-end solutions and create new paths for our customers to develop and commercialize their therapies,” Alistair Macdonald, chief executive officer, Syneos Health, said.
Double whammy
for Axovant as Ramaswamy’s second drug receives a setback
In September this year, PharmaCompass had reported how Axovant Sciences’ experimental drug intepirdine, a treatment for mild to moderate Alzheimer’s disease, had failed co-primary efficacy endpoints.
Earlier this week, Axovant scrapped its intepirdine program following the failure of its lead experimental treatment in a mid-stage study on patients suffering from a type of dementia.
“Based on the totality of intepirdine data to date, there is no evidence to support its further development,” Axovant’s CEO David Hung said in a statement.
Cast off specialist Vivek Ramaswamy had bought the failed Alzheimer’s drug from GlaxoSmithKline for US$ 5 million. But he sold it to investors in a record-setting IPO in 2015. Since then he’s garnered around US$ 2 billion for its startups that are buying experimental drugs from biopharma companies.
But things didn’t stop at the scrapping of intepirdine. Worse followed — in a bid to reduce the ‘intepirdine pain’, an Axovant press release issued earlier this week said it had spotted some hopeful signs in a post-hoc analysis on a separate study of nelotanserin.
But this was quickly followed by a rather embarrassing correction — that the company incorrectly reported the ‘p-value’ for the one clearly positive endpoint they had claimed was a sign that the nelotanserin was worthy of evaluation in a ‘larger confirmatory nelotanserin study’.
in a drug trial, ‘p-value’ denotes the level of marginal significance within a statistical hypothesis test representing the probability of the occurrence of a given event.
If the ‘p-value’ is less than 0.05, it usually means that a significant difference does exist between two trial datasets. However, if the ‘p-value’ is larger than 0.05, then one cannot conclude that a significant difference exists.
Axovant’s first press release issued said their post-hoc subset analysis of Parkinson’s patients with a baseline SAPS-PD score (a scale for assessing positive systems in Parkinson’s Disease) greater than 8.0 (n=19) showed that a 40 mg for two weeks followed by 80 mg for a fortnight did indeed result in a 1.21 point improvement. However, Axovant’s p=0.011 figure was incorrect.
In fact, it was much worse at p=0.531.
The faux pas indicated that instead of having hopes on nelotanserin, it had more reason to doubt its success. And instead of going to the US Food and Drug Administration (US FDA) looking for guidance on next steps in investigating the drug in patients with dementia with Lewy bodies (DLB) motor function deficits and patients with more severe baseline psychotic symptoms, Axovant will be sticking with just DLB patients with motor function deficits.
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