Otsuka (OTSKF -0.4%) gets a positive CHMP opinion for the tuberculosis drug delamanid.
The decision marks a change of heart for the committee, which adopted a less sanguine opinion in July citing the need for further study.
Now, the panel is backing "conditional approval" — "after studying the data again and consulting with infectious disease experts, [the CHMP] determined that it was likely the drug would be effective over six months, as it had been in the two-month study," WSJ notes.
Sarissa Capital formally announces its intention not to tender any of its shares for the $8.50 per share takeover offer of Astex Pharmaceuticals (ASTX -0.4%) by Otsuka Holdings (OTSKF.OB). The activist investors also urge fellow Astex shareholders not to tender their holdings for that price either.
Sarissa calls out Astex management for failing to respond to any of its concerns and instead trying to scare shareholders into voting for the deal by suggesting Otsuka could just up and walk away. "Given the built-in mandatory offer extensions in the Astex-Otsuka transaction agreement that we outlined in our October 2 letter, we don't believe any such 'substantial additional risk' exists. But most importantly, we do not believe that $8.50 is an adequate price."
Lazard Capital is excited about Sativex maker GW Pharmaceuticals (GWPH).
Market chatter suggests Joshua Schimmer has raised his price target on the shares to $65 (from $22) for upside potential of 163%.
Apparently, the company's Otsuka-partnered (OTSKF.OB) epilepsy program is "one of the most compelling opportunities [Lazard] has ever seen."
Here's what the company has to say about that program: "By studying the impact of cannabinoid addition on the amplitude of the epileptiforms produced, researchers are able to recognize if compounds could perform as an anti-epileptic drug in vivo."
Activist shareholder Sarissa Capital opposes Otsuka Holdings' (OTSKF.OB) $886M bid for Astex Pharmaceuticals (ASTX), saying the $8.50-a-share offer is too low, although the U.S. biotech firm disagrees.
Sarissa, founded by former Carl Icahn associate Alex Denner, has also raised questions about the timing of the auction for Astex. The process came ahead of the release of key data for cancer drug SGI110, which is expected in December.
Sarissa is contacting potential bidders that the firm believes were left out the bidding process. Astex counters that it reached out to 33 companies but only Japan-based Otsuka made a final bid.
As tipped Wednesday, Japanese drugmaker Otsuka Holdings (OTSKF.OB) is set to buy Astex Pharmaceuticals (ASTX) for around $886M in the largest deal for the Tokyo-based company since it snapped up a 49% stake in a French mineral water bottler five years ago.
Otsuka expects to launch a tender offer at $8.50/ share "within 10 business days."
The deal increases the profile of Otsuka's oncology business and strengthens its pipeline as it prepares for patent expiration on Abilify.
The Department of Health & Human Services is investigating the use of anti-psychotic drugs to treat Medicaid recipients aged 17 and under amid concern that the medicines are being over-prescribed. HHS wants to tighten oversight across the nation.
The probe focuses on the five largest Medicaid states: California, Florida, Illinois, New York and Texas, and covers a period from January-June 2011, when 84,654 children received treatment. Other than that, the most recent data seems to date back to 2008.
Medicaid spends billions of dollars a year on the drugs, which include those made by AstraZeneca (AZN), Eli Lilly (LLY) and Johnson & Johnson (JNJ), as well as by Otsuka Holdings (OTSKF.OB), the provider of Abilify, the top prescription drug by revenues in the U.S.