Market Place
This week, Phispers brings you two tales of alleged misuse of information involving former employees of Teva and AstraZeneca. Latin America is presenting more challenges for pharma MNCs, especially with Brazil under recession. Meanwhile, FDA is investing US$ 500 million under the Cures Act, passed by the Obama Administration in December last year. And Eli Lilly has won a long-drawn patent dispute against Actavis over its cancer best-seller.
Teva sues ex-exec romantically involved with Apotex’s CEO
Last week, Teva filed a lawsuit against its ex-employee Barinder Sandhu who was Senior Director, Regulatory Affairs, US Generics at Teva USA, until her termination in October, 2016.
Also named in the lawsuit is Jeremy Desai, who is President and CEO of Teva’s direct competitor — Apotex, a Canada-headquartered drug firm.
Teva has claimed that Sandhu breached her confidentiality agreement by sharing trade secrets and other confidential information to benefit Apotex’s own competitive product development.
According to the lawsuit, Sandhu “emailed Teva USA documents containing trade secrets and other confidential information, many specifically marked ‘Confidential’, to Desai at his Apotex email account.”
She also allegedly sent information to her personal email account, in violation of Teva USA’s policies, used USB flash drives on her work-issued computer laptop and used a cloud-based drive to share “hundreds of Teva USA documents”.
The information shared by Sandhu relates to a project whose identity has been concealed in the lawsuit as ‘Product X’. Teva claims that Desai and/or Apotex used the “misappropriated information to gain a competitive advantage over Teva USA”.
According to the complaint, Apotex employees openly discussed Teva USA’s trade secrets and other confidential information related to ‘Product X’ and participated in roundtable discussions in an effort to advance Apotex’s potential market position of its competing generic product.
The lawsuit mentions that in the summer of 2016, Teva USA learned through a former Apotex employee that Sandhu had provided Desai with a copy of highly confidential correspondence from the FDA to Teva USA known as a Complete Response Letter (“CRL”).
This letter from the FDA provided comment on an application for ‘Product X’, which was circulated amongst Apotex employees.
After accusing former protege of info misuse, is AstraZeneca’s CEO leaving to take the top job at Teva?
There was more news last week, pertaining to the potential misuse of confidential information — AstraZeneca accused former executive Luke Miels of misusing confidential information and documents to win the top pharma job at GlaxoSmithKline.
According to court documents obtained by the Times, Miels alleged that Pascal Soriot, AstraZeneca CEO and Miels’ former mentor, took Miels' decision to resign and join GSK very personally and “sought to threaten and punish” him by enforcing a 12-month notice period.
AstraZeneca, on the other hand, alleged that Miels, who was paid US$ 1.67 million (£1.3 million) last year, “had access to information that was confidential beyond his 12-month notice period” that would damage Astra if it was obtained by a competitor.
Miels’ lawyers responded by stating that AstraZeneca was in no position to complain about him using AstraZeneca’s documents in his job negotiations since AstraZeneca had shared confidential information with Soriot before he left Roche to become Astra’s CEO.
The story may take another unexpected twist as Israeli news reports say that AstraZeneca CEO Pascal Soriot has agreed to take the top job at Teva. Soriot is expected to earn twice as much as Teva’s previous CEO and receive a bonus upon signing the contract, estimated at about $20 million.
Pfizer bows out with sale of Teuto in
Brazil
Not long ago, Brazil was one of the hottest emerging markets for drugs, and big pharma were lining up to cash in on this opportunity. Today, Brazil is in the midst of a historic recession that has dampened drug demand.
Back in 2010, when the going was good, Pfizer had struck a US$ 240 million deal for a 40 percent stake in the Brazilian generic drug firm — Laboratório Teuto Brasileiro. But the joint venture never really took off. And recently, Pfizer has accepted a payment of 1 Brazilian Real — or US$ 0.30 — to relinquish its stake to the heirs of Laboratório Teuto’s founder.
For nearly a year, Pfizer had been trying to offload Teuto. A spokesperson for Pfizer said: “Since 2010, both companies have worked together to improve access to medicines in Brazil.” However, Pfizer arrived at this decision as a result of a “desire to focus resources on ensuring the success of its existing portfolio and pipeline.”
Pfizer’s exit follows challenging acquisition experiences by Sanofi and Teva in Latin America.
Eli Lilly wins patent dispute against
Actavis over its best-selling cancer drug
Last week, Eli Lilly won a long-drawn patent dispute with Actavis after the UK Supreme Court ruled that the generic drugmaker's versions of Lilly's top-selling cancer drug — Alimta — directly infringes on certain Lilly patents in Britain, France, Italy and Spain.
The generic version of Alimta (pemetrexed) is now owned by Teva, after it bought Allergan's generic business — Actavis — in August last year.
Alimta is Lilly's top-selling oncology treatment. It generated sales of US$ 2.3 billion last year.
This decision reportedly applies to about US$ 300 million worth of annual sales.
Merck’s purchase of Sigma Aldrich under EU scanner
The European Commission has raised objections to the purchase of Sigma Aldrich by German drugmaker Merck. In a Statement of Objections sent out to Merck and Sigma-Aldrich, the Commission alleged that these companies breached EU merger rules. The companies could face a fine equivalent to 1 percent of the combined firm’s annual revenue, the Commission said.
According to the Commission, when Merck and Sigma-Aldrich disclosed their merger plan in 2015 they did not share details of a project “with relevance for certain laboratory chemicals at the core of the Commission’s analysis.”
The Commission said the project was being developed by one of the parts of the Sigma business that was acquired by Honeywell in October 2015. The technology developed as a result of the project was subsequently licensed to Honeywell, the Commission added.
“Honeywell now has the technology it should have received with the divested business. However, this happened with a delay of almost one year and only because the Commission was subsequently made aware of the issue by a third party,” the Commission said.
FDA to invest US$ 500 million innovation
fund under Cures Act
Last week, the FDA laid out its plans of investing the US$ 500 million innovation fund earmarked in the 21st Century Cures Act, passed last year under the Obama Administration. The fund will be spent from this year, until 2025, and is subject to annual appropriations from the US Congress.
Scott Gottlieb, FDA’s Commissioner, in a blog post, said the agency’s plans for investing the innovation fund are steps that will both improve public health (by facilitating biomedical innovation) and reduce drug costs (by cutting the burden of unnecessary regulation).
FDA’s plans for the innovation fund include allocating US$ 25.8 million to advance patient-focused drug development, and US$ 95.3 million to regulatory science initiatives, including qualification of drug development tools such as biomarkers. It also plans to streamline the regulation of targeted drugs for rare diseases, and to award grants to advance continuous manufacturing technology. The largest expenditure from the innovation fund — US$ 168.2 million — is earmarked for FDA’s initiatives designed to improve the collection of evidence about safety and efficacy.
“FDA’s headway in pursuing the opportunities enabled by Cures illustrates the agency’s enthusiasm and commitment to the law—both its letter and its spirit,” Gottlieb said in his blog.
Did Gilead use Chinese API claiming it came from an approved
South Korean manufacturer?
The United States Court of Appeals for the Ninth Circuit reversed a federal judge’s 2015 ruling in the Gilead Sciences’ case. The US drugmaker is back in court to defend accusations that it made false statements about complying with federal regulations on HIV drugs.
There were allegations that Gilead had netted billions of dollars in government purchases, and that it had fired a whistleblower — a senior employee who spoke against the company’s illicit conduct.
The ex-employees claim that Gilead used a company called Synthetics China to produce unapproved emtricitabine, at unregistered facilities, to save money.
For almost one and a half years, beginning in 2007, Gilead imported emtricitabine API from Synthetics China to use in its finished drugs, claiming that the API had come from its approved South Korean manufacturer.
Emtricitabine is used by Gilead to produce several HIV drugs, such as Atripla, Emtriva and Truvada.
The Ninth Circuit three-judge appeals panel held that former Gilead employees Jeff and Sherilyn Campie had adequately pleaded that Gilead’s conduct opened it to liability under the False Claims Act (FCA). In 2008 and 2009, the government paid more than US$ 5 billion for the HIV drugs, the court held.
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