Pluristem received approval to initiate the phase II trial using PLX-PAD cell for the treatment of intermittent claudication

Pluristem announced that the US FDA has allowed the company to initiate the phase II trial evaluating its PLX-PAD cell product candidate for the treatment of intermittent claudication, a subset of peripheral artery disease.
The phase II trial will aim to evaluate the safety and efficacy of 2 doses of PLX-PAD cells against placebo. The agent will be administered via two intramuscular

Auxilium received paragraph IV notification for Testim

Auxilium pharmaceuticals and FCB I LLC announced that the companies have received paragraph IV certification notice indicating that Watson has filed an abbreviated new drug application containing a paragraph IV certification under 21 USC Section 355(j) for testosterone gel. The certification notice refers to the nine US Patents covering Testim 1% (

Cyclacel received US patent for sapacitabine

Cyclacel announced that it has received a new US patent covering sapacitabine of which the company has patent exclusivity until July 2030. The patent number is 8.123.593 and titled “Methods of Treatment Using Sapacitabine”. The patent covers a method for treating proliferative diseases, including leukemia, MDS, solid tumors and lymphoma using 7-day or 14-day of sapacitabine regimens in a 21-day cycle. The method also specify the dosing of sapacitabine (once daily or twice daily).

Sapacitabine is an orally-available nucleoside analogue. The agent works to cause a novel DNA single-strand break which leads to the production of DNA double-strand breaks and/or checkpoint activation. It is currently being evaluated in a registration-directed phase III trial (SEAMLESS) in elderly patients with newly diagnosed acute myeloid leukemia. It’s being studied in phase II trials in patients with hematological malignancies including myelodysplastic syndromes, cutaneous T-cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma, and non-small cell lung cancer. It’s being studied in a phase 1 trial in patients with advanced solid tumors as in combination with seliciclib

Merck entered into an exclusive agreement with Endocyte

Merck announced that it has entered into an agreement with Endocyte to develop and commercialize vintafolide.

Vintafolide is currently being studied in the phase III trial for the treatment of platinum-resistant ovarian cancer. IT is also being studied in the phase II trial for the treatment of non-small cell lung cancer.  In both studies, vintafolide is being used in combination with the diagnostic agent etarfolatide (EC20)

Under the agreement, Merck will pay Endocyte a $120M initial upfront payment. Endocyte is eligible to receive up to $880M depending on the clinical, regulatory and commercial path of vintalofide for a total of six cancer indications. Endocyte is also entitled to receive

Eisai launched Lunesta in Japan

Eisai announced that it has launched eszopiclone (Lunesta) in Japan for the treatment of insomnia. This mark the first non-benzodiazepine GABAa agonist that is launched in Japan in 12 years. Lunesta has been launched in the US since 2005 for the treatment of insominia.

Lunesta was originally developed by Sunovion (now part of Dainippon Sumitomo Pharma).  Eisai has acquired development and market rights to eszopiclone from Sunovion (formerlly known as Sepracor) in Japan. The product was approved in Jan 2012 and was listed on the National Health Insurance on April 17.

Lunesta will be available in 1 mg, 2 mg and 3 mg tablets. The prices are 49.6 yen, 78.7 yen and 99.8 yen respectively. The Japanese package insert recommends a dose of 2 mg for non-elderly adults and 1 mg for elderly adults taken immediately before bedtime orally. Maximum dose for non-elderly adult is 3 mg and for elderly adult is 2 mg.

Vanda acquired rights to NK-1 Receptor Antagonist from Lilly

Vanda announced that it has acquired rights to develop and commercialize NK-1 receptor agonists from Eli Lilly and Company for all human indications with $1M initial license fee and up to $95M in future regulatory approval and sales milestones. 

NK-1 receptor antagonists have been studied for several indications: chemotherapy-induced nausea and vomiting, post-operative nausea and vomiting, alcohol dependence, anxiety, depression, and pruritus. Currently, the only NK-1 receptor antagonist that is marketed in the US is Emend (aprepitant). The agent is being marketed by Merck for the prevention of post-operative nausea and vomiting.

VLY-686 has been shown to reduce alcohol cravings and voluntary alcohol consumption in patients who had alcohol dependence. The study was conducted by the NIH. Formerly known as LY686017, VLY-686 has been granted a patent as a new chemical entity that will expire in April 2023 worldwide except in the US where the patent will expire in June 2024.

Roche issued statement in regard to Illumina's offer

Roche just continues to send message about Illumina's offer.

After sending its message to Illumina shareholders, the company immediately released a statement in regard to the offer.  The statement somewhat repeated the information that was mentioned in the letter to Illumina shareholders.

The company emphasized that it would consider negotiation as long as Illumina is willing to do so. At this present time, based on Roche's information, Illumina has "refused to enter into negotiations" with the company. As a result, the proposed offer is given based on the publicly available information.

If you are not familiar with the subject, Roche originally offered to acquire Illumina for $44.5 a share. The offer was then raised to $51 per share in March. This represented a 88% premium of Illumina's closing stock price on Dec 21, 2011 which was when the rumor about the acquisition started. Since then, the company has yet to made any progress in the acquisition.

Illumina annual shareholder meetings will occur on April 18, 2012.

Mylan begins shipment of generic Lescol (fluvastatin)

Mylan announced that the company has received the approval from the US FDA to market generic Lescol (fluvastatin) 20 mg and 40 mg capsules. This marks the first generic version of Lescol marketed by Novartis. Novartis has granted Mylan a license permitting