Valeant to acquire certain assets from Swiss Herbal Remedies

Valeant announced that it has entered into an agreement to acquire certain assets from Swiss Herbal Remedies, a private Canadian-based company, with C$28M.  The company was founded in 1967.  You can learn more about the company at its website.

Swiss Herbal Remedies is a nutraceuical company that manufactures and markets a broad range of products including scientifically formulated vitamins, minerals and supplements.

Valeant said the company expects the transaction to close by June 2012.

Takeda to acquire a Brazilian company Multilab

Takeda announced that it has entered into an agreement to acquire Multilab of Brazil with an upfront payment of 500 M Brazilian Real in cash and up to 40M Brazilian Real in future milestone payments to Multilab owners . The acquisition will enhance the company's presence in Brazil and makes it become one of the top ten pharmaceutical companies in Brazil.  Takeda has already established its presence in Brazil with manufacturing facility and marketing department. Several of the company's well-known brands are Neosaldina, Eparema and Nebacetin (all are over-the-counter products).

Multilab is a mid-sized pharmaceutical company based in Brazil. The company was established in 1988 and markets multiple products in the markets including branded generics and over-the-counter products.  Multilab market Multigrip which is one of Brazil's best-selling over-the-counter product for cold and flu treatment. Over a three year periods, the retail sales for the company has grown in excess of 20% p.a.  Multilab currently has approximately 650 employees.

Watson confirmed lawsuit filed by Auxilium in regard to Testim 1%

Watson announced that the company has received a patent infringement lawsuit filed by Auxilium in regard to the company's abbreviated new drug application submitted for Testim 1% (testosterone gel) currently marketed by Auxilium for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

The lawsuit was filed on May 23, 2012 against Watson in the US District Court for the District of New Jersey. It was filed under the provisions of the Hatch-Waxman Act and subsequently makes the FDA unable to approve the ANDA submitted by Watson for up to 30 months or until the final resolution has been made between the two companies before the court, whichever occurs sooner.

Based on IMS Health data, sales of Testim 1% was estimated to be at $260M in the 12 months ending March 31, 2012.

Mylan launched generic Viramune

Mylan announced that it has launched generic version of Viramune (brand name of nevirapine) as a component of the combination antiretroviral treatment of HIV-1 infection.

Sales of nevirapine 200 mg was estimated at $116M for the 12 months ending March 31, 2012 based on IMS Health.

Nevvirapine is a non-nucleoside reverse transcriptase inhibitor . It binds to reverse transcriptase, an enzyme that is required for HIV replication in the cells, to deactive the enzyme. This leads to the inhibition of HIV replication in the cell.

Xiangxue acquires KX02 rights from Kinex in certain territories

Chinese firms are taking the US products by storms!

Asides from Pharmaceutical industry, AMC was recently bought be a Chinese company for $2.6B and Yahoo sells half its its stake to Alibaba, a chinese e-commerce website, for $7.1B.  These are not small transaction.

Kinex Pharmaceuticals of Buffalo, NY announced that Xiangxue Pharmaceuticals has acquired exclusive rights to the company's KX02 for all oncology indications in greater China territory (China, Hong Kong, Taiwan) and Singapore.

Under the terms of the agreement, Xiangxue Pharmaceuticals will now be responsible for all clinical and regulatory development as well as the associated costs in licensed

US Marshals seized products at Crescendo Therapeutics of Vista, CA following two warnings

When the FDA said no, the company should have behave...

The FDA reported that the US Marshals had seized Hybrisil topical corticosteroid, an unapproved new drug, from Crescendo Therapeutics of Vista, CA after the Agency has warned the company not to market HybriSil (methylprednisolone 1% in silicone gel).

The FDA has conducted two inspections with the first one took place in April 2011 when the Agency discovered that the company was marketing HybriSil as a prescription topical corticosteroid for the treatment of scars and skin disorders. The FDA had issued a warning to the company demanding the company to stop marketing the product without the US FDA approval which would require data showing that the product was safe and effective for the treatment purpose.  In Jan 2012, Crescendo submitted an investigational new drug application to ask for limited distribution of HybriSil for investigational use only. Another inspection from the FDA showed that the company continued to market HybriSil for non-investigational purposes. In addition, the Agency also found that the product label lacked adequate instruction for use. Thus this makes the product misbranded.

Auxilium and GSK to co-promote Testim

Auxilium Pharmaceuticals announced that it has entered into an agreement with GlaxoSmithKline to co-promote Testim 1% (testosterone gel) for the testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone.

Under the terms of the agreement, GSK now has exclusive rights to co-promote the sale of Testim with Auxilium in the US until Sep 30, 2015.  GSK will utilize its