This week, Phispers brings you news of an impending mega-merger in the field of APIs, a trade body’s claim that Brexit won’t be good for patients in the UK and Medivation’s change of heart regarding a sell-off.Court finds Ranbaxy’s Singh brothers concealed and misrepresented information
A Singapore
court has ordered Malvinder and Shivinder Singh – former owners of Indian drug maker Ranbaxy – to pay US $ 529 million (GBP 367 million) to Japan’s Daiichi
Sankyo and settle
arbitration. The award pertains to the accusation by Daiichi that the
Singh brothers had concealed and misrepresented information regarding US Food
and Drug Administration (FDA) and Department of Justice (DoJ) investigations
when Daiichi bought 35 percent stake in Ranbaxy from them in 2008. Daiichi sold its entire stake in Ranbaxy in 2015, when Sun
Pharma acquired Ranbaxy for US $ 4 billion. In 2013, Ranbaxy was fined US $
500 million in the FDA and DoJ investigation for knowingly selling substandard
drugs as a result of manufacturing and regulatory failings.In another blow to Ranbaxy (now Sun Pharma), the Indian
drug regulator is following up on the action taken by state regulators on
observations made by the Indian central drug authority during the June-July
2013 period. A reminder was sent to the
state drug regulator in June 2015 as there has been no action from the local
authority. AMRI and Euticals sign definitive agreement for an API mega-mergerOn May 5, Albany Molecular Research Inc. (AMRI) signed a definitive
agreement to acquire all outstanding shares of Italy-headquartered Prime
European Therapeuticals (or Euticals, as it is popularly known). The transaction has been valued at
around US $ 358 million and consists of shares of AMRI common stock, cash, and
a seller note. Privately-held Euticals specializes in custom synthesis and the
manufacture of APIs. It operates API facilities in Italy, Germany, US and France. “Euticals’ expertise with niche and high barrier to entry technologies and products, including certain tetracyclines,
monobactams, sterile and fermented APIs and controlled substances, will be a tremendous asset to us,” William S. Marth, AMRI's president and chief executive officer, said.AMRI generated approximately $402 million of revenue in the twelve months ended December 31,
2015 however declared a first-quarter loss of $10.1 million this week. AMRI’s proposed acquisition of Euticals will increase revenue by around $245 million. Endo feels the pain as Valeant’s new CEO makes headlinesAs Valeant Pharmaceuticals' new CEO Joseph Papa takes charge, Irish-domiciled
specialty pharma company Endo, which is
known to mimic Valeant, is feeling the pain. As with Valeant, Endo
is under pressure to lower prices, especially for its pain products. Mimicking what Valeant did in March, this week Endo slashed
full-year revenue guidance it had recently put out. The US $ 500 million cut in
guidance was much larger than what anyone had expected.Endo is run by Valeant's former COO, Rajiv De Silva and has,
like Valeant, tended to buy older drugs, used inversions to lower tax rates,
and built up debt with a series of acquisitions. Meanwhile, Papa
told CNBC that he is “not in it for money”. Valeant is learnt to pay Papa US $ 67.4 million in cash, options and restricted stock this year. “To me this is all about if I can play a small role in improving Valeant...,” he said. Brexit could put
patients at risk in the United KingdomBritain's pharmaceuticals trade body – the Association of the British Pharmaceutical Industry (ABPI) – has voiced concerns
about Brexit. It has said if the country was to exit the European Union, it
would put British patients at the back of the line for new medicines. ABPI chief executive Mike Thompson said his members were “overwhelmingly supportive of remaining in the EU”, especially given the concerns over disruption to the pan-European drug approval system provided by the European Medicines Agency (EMA). “If we left the EU, this would mean that the licensing of new medicines would have to be handled by a UK agency as well as a European agency,” Thompson said. According to him, ABPI members have confirmed that applications for a UK license would come “after the European license, due to the smaller patient population in the UK.” Medivation succumbs
to sale pressure, starts exploring optionsUS cancer drug maker Medivation Inc. is reportedly now open
to a sale, after France’s Sanofi SA made a US
$ 9.3 billion offer to buy the company on April 28. Among the other companies
that have signed a non-disclosure agreement with Medivation are Pfizer and Amgen. The
agreement allows them to obtain confidential information about Medivation. Earlier, Sanofi had complained that Medivation was refusing to engage in negotiations. Last week, Medivation had said Sanofi's US $ 52.50 per share cash offer “substantially undervalues the company.” Sanofi is said to be willing to raise its offer as long as Medivation engages in negotiations. Sanofi has also threatened to go directly to shareholders to oust Medivation’s board if it does not engage in negotiations.
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