Market Place
This week, Phispers brings you news on Japanese drugmaker Takeda, which has shown interest in buying Irish pharma company Shire — a deal tipped to cost over US$ 50 billion. In the midst of all the recent challenges, Dr Reddy’s Laboratories gets a new COO. The Indian drug major has also filed a new drug candidate for migraine with the USFDA. A US federal judge overturned the verdict in Teva-GSK patent infringement case over GSK’s blood pressure drug Coreg. In other news, FDA rejected Alkermes’ key depression drug; chief said the agency would speed up approvals of biosimilars; Apple launched Health Records in certain health systems in the US; and Eisai struck an alliance with Nichi-Iko to exit generics.
Takeda
confirms its interest in Shire, which could cost more than US$ 50 billion
This year surely seems to be a big one for M&As. After mega deals like Sanofi’s buyout of Bioverativ for US$ 11.6 billion and Juno Therapeutics’ acquisition of Celgene in a deal worth US$ 9 billion in January, there is news that Japanese drugmaker Takeda Pharmaceutical is interested in buying Irish drug firm Shire.
In a press statement, Takeda said its “consideration of such an offer is at a preliminary and exploratory stage and no approach has been made to the Board of Shire.”
“Takeda believes that a potential transaction with Shire presents an opportunity to advance Takeda’s stated Vision 2025,” it added. The acquisition would strengthen Takeda’s core therapeutic areas of oncology, GI and neuroscience, the statement said.
Shire has been a buyout target for quite some time now.
Analysts, however, cautioned that financially, the ‘deal looks stretched’. According to their calculations, if Takeda can pull off a deal, it’ll have to cough up more than Shire’s market cap (which is around US$ 52 billion), and give Shire shareholders 40 percent ownership of the combined company.
“We expect the public announcement ahead of approaching Shire probably has to do with management reluctance to consider equity-heavy ~£40/US$ 170 offer and starting a dialog with shareholders on this issue,” research firm Bernstein said.
Dr Reddy’s gets new COO; files new drug candidate for migraine with USFDA
There is a change of guard at the Indian drug major Dr Reddy’s Labs (DRL). Chief operating officer Abhijit Mukherjee retired on March 31, 2018, after a 15-year stint at the company.
He has been replaced by Erez Israeli. He will report to DRL’s co-chairman and CEO, G V Prasad. Israeli has worked for Teva Pharmaceuticals for 23 years.
Mukherjee’s tenure as the COO was marked by unexpected challenges. DRL’s product approvals for the US slowed down as the US Food and Drug Administration (FDA) noted lapses at its critical manufacturing site.
Israeli will have to use his experience to take a hard look at DRL’s key strategies. The company’s US revenue in the last financial year (at US$ 978.1 million or INR 63.600 billion) was down 16 percent from its FY16 revenue (at US$ 1.16 billion or INR 75.45 billion). The decline was worsened by higher competition in specialized segments such as injectables, the company said. Its pharmaceutical services and API business saw a 5 percent drop in revenues for FY17.
Tackling the challenges won’t come easy. Factors like the much-feared consolidation of the supply chain in the US may shave off margins even further. President Donald Trump has often indicated a crackdown on the pharma industry over high drug prices.
Meanwhile, DRL’s subsidiary, Promius Pharma, filed a New Drug Application (NDA) for its migraine candidate DFN-02 with the FDA.
According to Dr Anil Namboodiripad, senior vice president, Proprietary Products and president, Promius Pharma, the NDA for DFN-02 is an important step forward in the company’s mission to bring solutions that address unmet needs.
“In a multi-center, double-blind, randomized, placebo controlled study with 107 subjects, DFN-02 has demonstrated that it can effectively treat pain and associated symptoms during a migraine attack and reduce attack-related functional disability,” a company statement said.
FDA rejects Alkermes’ key depression drug; Roche addresses Hemlibra concerns
Irish drugmaker Alkermes lost a high-stakes gamble last week when the FDA did not approve its big depression drug on the basis of a single positive Phase III study.
According to a company statement, the FDA is demanding more clinical trials to provide a full set of data as well as a “bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.”
Meanwhile, Alkermes executives served notice that they plan to appeal the decision.
“We strongly believe that the clinical development program, including data from more than 1,500 patients with MDD (major depressive disorder), provides substantial evidence of ALKS 5461’s consistent antidepressant activity and a favorable benefit-risk profile,” Richard Pops, CEO, Alkermes said.
“To say we were surprised is an understatement,” Pops said in a call with analysts.
Meanwhile, Roche is offering some additional details on the five deaths they’ve recorded among hemophilia patients who were taking Hemlibra. The company has reiterated that the risk/benefit profile of the would-be blockbuster remains unchanged, as Roche is conducting an “ongoing” probe into two recent cases.
According to a company spokesperson, two new deaths were recorded recently which physicians linked to a pre-existing condition in one case and a major vascular surgery in another. Those cases followed deaths associated with a rectal hemorrhage and two intracranial hemorrhages.
These deaths have resurfaced lingering safety concerns about the drug, which analysts believe has been on track to rack up US$ 4 billion to US$ 5 billion in annual sales.
Judge
overturns verdict in Teva-GSK patent infringement case over BP drug
Last week, a federal judge overturned a US jury’s verdict that required Teva Pharmaceutical to pay GlaxoSmithKline more than US$ 235 million (£167 million) for infringing a patent covering its blood pressure drug Coreg.
The judge ruled the evidence did not support the jury’s finding in June 2017 that Teva’s sales of a generic version of the drug caused doctors to infringe GSK’s patent.
Last year, the jury had awarded GSK US$ 234.1 million in lost profits and had said the British drugmaker deserved an additional US$ 1.4 million in royalties. It had also rejected Teva’s contention that the patent was invalid.
“We are disappointed with the judge’s decision and are reviewing our options,” GSK said in a statement.
GSK had alleged that while Teva’s FDA application had a carve-out to address its use for treating chronic heart failure, which GSK said remained under patent; Teva changed its label in 2011 to add that use. As a result of this, GSK said Teva led doctors to infringe its patent by selling a generic version of the drug and marketing it as a substitute for Coreg.
But in his ruling last week, the judge said evidence did not support the finding that Teva’s actions (as opposed to other factors) induced doctors into infringing the patent by prescribing generic carvedilol to treat chronic heart failure.
“Without proof of causation, which is an essential element of GSK’s action, a finding of inducement cannot stand,” the judge wrote.
Meanwhile, Teva has joined the club of drug companies that pay hefty salaries to their executives. It is doling out US$ 17 million to its new CEO Kare Schultz
That’s more than double the amount Teva paid former CEO Erez Vigodman in 2016, his last full year on the job. Vigodman took home emoluments of US$ 6.5 million that year.
FDA
to speed up biosimilar nods; HHS hires former CVS exec to lower drug prices
The FDA is working on around a dozen actions to boost the use of cheaper versions of expensive biotech medicines, Commissioner Scott Gottlieb said last week.
The US has lagged behind Europe in the use of biosimilars, much to the frustration of the FDA policymakers. Biosimilars for treating serious conditions such as cancer and rheumatoid arthritis are complex molecules made inside living cells.
“There’s no silver bullet here in terms of trying to make this market really go gangbusters. I think this is going to be a slow build,” Gottlieb said at a conference in New York.
“We’re going to be coming out with a set of policies, multiple policies, about a dozen policies that I think incrementally will each move the ball in a direction trying to create more avenues for biosimilar competition,” he added.
In a recent interview to CNBC, Gottlieb said: “I think we will see a lot of biosimilar competition come on to the market. And I also think we’re going to see more consumer and provider acceptance of using biosimilars.”
Meanwhile, Health and Human Services (HHS) Secretary Alex Azar has hired former CVS Caremark executive Daniel Best to lead the agency’s efforts to lower drug prices.
According to HHS, Best will be Azar’s senior adviser for drug pricing reform. Best was most recently a vice president of industry relations for CVS’s Medicare Part D business. In a statement, Azar said Best will lead the agency’s initiatives aimed at lowering drug prices — a top priority for the Trump administration.
Apple
Health rolls out of beta, launched in 40 hospitals in the US
Apple introduced an updated version of its software (iOS 11.3) last week with a new feature — Health Records. Patients in the US of certain health systems — such as NYU Langone Health and Stanford Health and 40 other health systems representing hundreds of hospitals and clinics — can view their medical records on their iPhone.
Health Records keeps the information handy for the patient to view and hand over to doctors. This is easier than carrying around an entire medical file. All data contained will be encrypted and protected with the user’s iPhone passcode.
The updated Health Records section within the Health app helps consumers see medical information from various institutions organized into one view and receive notifications when their data is updated.
This information can help patients better understand their health history, have informed conversations with physicians and family members, and make future decisions.
“We view the future as consumers owning their own health data,” Apple chief operating officer Jeff Williams, said in an interview.
After
deal with Merck, Eisai strikes another alliance with Nichi-Iko to exit generics
Less than a month back, Tokyo-headquartered Eisai had entered into a global strategic collaboration with Merck for cancer drug Lenvima (lenvatinib mesylate). As per the agreement, the two companies will jointly develop and commercialize Lenvima as monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for multiple cancer types.
And now, Eisai has decided to bow out of the generic supply business by transferring the entire stake in its wholly-owned subsidiary, Elmed Eisai, to leading Japanese generic maker Nichi-Iko Pharmaceutical for roughly 17.12 billion yen (US$ 161 million). The transaction is expected to be completed in April 2019.
Eisai will promote collaboration on superior API supply with Nichi-Iko on various points such as price, quality and stable supply originated from Eisai’s Vizag plant in India.
Elmed Eisai was established as a wholly-owned subsidiary of Eisai in 1996, and with the concept of developing value-added generic drugs that are accessibly priced and easy for patients to administer. Established in 1965, Nichi-Iko is one of Japan's largest generic manufacturers.
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