Watson launched generic version of Prometrium

Watson has launched generic version of Prometrium (progesterone) capsules 100 mg and 200 mg as part of an agreement with Abbott Laboratories.

Prometrium has been indicated for the prevention of endometrial hyperplasia in non hysterectomized postmenopausal women who are receiving conjugated

Arena submitted the marketing authorization aplication for lorcaserin in the EU

Arena Pharmaceutical announced that it has submitted the Marketing Authorization Application to the European Medicines Agency for lorcaserin seeking approval to market the drug candidate for weight management in patients who are obese having BMI  of 30 or higher or patients who are overweight having BMI of 27 or higher and have at least one weight-related co-morbid

Bavarian submitted a marketing authorization application for Imvamune to the European Medicines Agency

Bavarian Nordic announced that the company has submitted a marketing authorization application for Imvamune to the European Medicines Agency.

The company is seeking to get approval to market Imvamune to immunize patients who are 18 years and older against smallpox infection and

Two pancrealipase formulations of Aptalis got approved from the FDA

Aptalis Pharma announced that the FDA has approved the company's Ultresa Pancrelipase delayed release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis  or other conditions and Viokace pancrelipase tablet for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy when used in combination with proton pump inhibitors.

Based on the FDA's approval, Ultresa consisting of porcine-derived lipases, proteases and amylases can be used in both children and adults. Ultresa comes in three strengths:

• 13,800 USP units of lipase, 27,600 USP units of protease, and 27,600 USP units of amylase
• 20,70 USP units of lipase, 41,400 USP units of protease, and

Opexa Therapeutics signed an agreement with Pharmaceutical Research Associaties

Opexa Therapeutics announced that it has entered into a strategic service agreement with Pharmaceutical Research Associates to seek support for the company's upcoming phase

Mylan launched first generic version of Lexapro

Mylan announced that the company has launched the generic version of Lexapro (escitaplopram tablet 5mg, 10 mg and 20 mg) for the acute and maintenance treatment of major depressive disorder and acute treatment of generalized anxiety disorder.

Lexapro is currently being marketed by Forest Laboratories.

Based on IMS Health data, the sales of Lexapro was estimated to be $2.9B for the 12 months ending on Dec 31, 2011.

Mylan will be able to market the product exclusively until the expiration of the pediatric exclusivity on the compound patent.

Takeda initiated the enrollment of the phase III trial evaluating Leuplin 6 month Depot in Japan

Takeda announced that the company has initiated the enrollment of the phase III clinical trials evaluating Leuplin 6 month depot for the treatment of prostate cancer and premenopausal breast cancer in Japan.

The two phase III clinical trials are multicenter, randomized, open-label, comparative studies. The company plans to enroll approximately 160 patients in each trial to evaluate the safety, efficacy, pharmacokinetics and hormone dynamics of the medicine.

The study primary endpoint is the suppression rate of serum testosterone to castrate level.  The study primary endpoint for the premenopausal breast cancer is the suppression rate of serum estradiol to menopausal level.

Leuplin 6 month Depot has been approved in the US and Europe. In the US, it has been approved for the treatment of endometriosis and uterine leiomyomata. In the US.

In Japan, Leuplin 1 month and 3 month formulations have been approved and marketed.

 Leuplin is a long-acting GnRH analog.

JHP signed a multi-year contract manufacturing agreement

JHP Pharmaceuticals announced that it has signed an multi-year contract with an undisclosed pharmaceutical company to manufacture an injectable anesthetic agent.

The product will be manufactured at the company's

Avanir entered into an exclusive license agreement with Concert

Avanir announced that it has entered into an exclusive license agreement with Concert Pharmaceuticals allowing Avanir to develop and commercialize Concert's deuterium-modified dextromethorpham for the potential treatment of neurological and psychiatric disorders.

Under the terms of the agreement, Avanir will make an upfront payment to Concert who will also be eligible to receive additional milestone payments once certain predefined clinical, regulatory and commercial targets have been achieved. In addition, Concert will also be eligible to receive tiered royalties on worldwide sales of products containing d-DM.

Avanir will be responsible for the overall responsibility for research, development and commercialization of d-DM.

Concert's deuterium-modified dextromethorphan has been issued US patent 7,973,049 in July 2011. Dextromethorphan is often seen as a cough suppressant.

Ultragenyx announced orphan drug designation for UX003

Ultragenyx announced that the FDA Office of Orphan Products Development has granted the company's UX003 orphan drug designation for the treatment of mucopolysaccharidosis type 7 (MPS7).

MPS7 is a rare autosomal recessive lysosomal storage disorder that are often characterized by a deficiency of the lysosomal enzyme beta-glucuronidase that are required for the degradation of the glycosaminoglycans dermatan sulfate (DS) and heparan sulfate (HS).

UX003 is a recombinant human beta-glucuronidase that has been studied as an enzyme replacement therapy for the treatment of MPS7.

Rare Disease Day!

Take a moment to recognize Rare Disease Day! 

This year the FDA will also host "the first FDA Rare disease Patient Advocacy Day on March 1, 2012. Some of the sessions will be webcast in order to increase the awareness within the rare disease community of the FDA's roles and responsibilities in the development of medical products for the diagnosis, prevention, and/or treatment of rare diseases or conditions."

For more information, please click here

 A few companies have also shown support and observed rare disease day. A few of them are Amylin (who launches disease awareness website dedicated to rare forms of lipodystrophy), Genzyme (who also launches its second annual global grant program to support non-profit organizations that work on behalf of patients living with lysosomal storage disorder), NPS Pharmaceuticals,

Cumberland and Harbin Gloria of China entered into an agreement

Cumberland announced that it has entered into an exclusive agreement with Harbin Gloria Pharmaceuticals of China allowing Harbin Gloria to commercialize Acetadote (acetylcysteine) and Caldolor (ibuprofen).

Under the terms of the agreement, Harbin Gloria will be responsible for the approval of the two products in China as well as the commercialization including product

Roche extends deadline to acquire outstanding shares of Illumina

Roche announced that it has extended the deadline to acquire outstanding shares of Illumina at a price of $44.5 per share. The new deadline has been set to be at 6:00 PM Eastern Time on March 23, 2012.

The previous deadline was at midnight on Feb 24, 2012. As of the past deadline, the company had acquired 102,165 shares including 44,152 shares guaranteed to be delivered within the next three NASDAQ trading days.

Greenhill & Co and Citigroup Global Markets are financial advisors to Roche while Davis Polk and Wardwell are its legal counsel.

BioSante announced positive results from the phase 1b study evaluating GVAX Pancreas Cancer

BioSante announced positive results of the phase 1b trial evaluating the company's GVAX Pancreas cancer vaccine in in patients with locally advanced or metastatic pancreatic adenocarcinoma that was previously treated in combination with ipilimumab.  The results showed that patients treated with the combination of GVAX Pancreas cancer vaccine and ipilimumab had an increase in median survival of 2.2 month.

BioSante plans to initiate additional clinical study

The European Medicines Agency accepted the marketing authorization application for peginesatide

Takeda announced that the European Medicines Agency has accepted the marketing authorization application submitted for peginesatide for the treatment of anemia associated with chronic kidney disease in patients on dialysis.  The news triggered a $5M milestone payment made to Affymax.

Peginesatide is a synthetic, pegylated peptidic compound

The FDA sent a complete response letter to Watson in regard to progesterone 8% gel

Watson announced that the company has received a complete response letter from the US FDA in regard to the New Drug Application submitted for progesterone vaginal gel 8% for its use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.

The FDA said the risk reduction in preterm birth in women with a short uterine cervical length did not meet the level of statistical significance that are often

Pfizer acquired Alacer

Pfizer announced that it has acquired a privately-held Alacer Corp, the company that makes and sells the largest selling vitamin C product line in the US.

Alacer is the marker and distributor of Emergen-C product lines. Emergen-C is an effervescent, powdered drink mix vitamin supplement that has presence in health food

Takeda announced positive results from the phase II trial evaluating the company's TAK-875

Takeda announced positive results from the phase II trial evaluating TAK-875, a GPR40 agonist, in the management of glycemic control in patients with type 2 diabetes.

It is a phase II randomized, double-blind, placebo- and active (glimepiride) controlled phase II trial. The study aimed to compare the effectiveness of TAK-875 given at the following doses 6.25 mg, 25 mg, 50 mg, 100 mg and 200 mg against placebo and glimepiride given at 2-4mg over 12 weeks in patients with type 2 diabetes.  The trial enrolled 426 patients whose blood glucose was not

Zelboraf got approval in the EU

Roche announced that the European Medicine Agency has approved Zelboraf (vemurafenib), the first and only personalized skin cancer medicine, for the treatment of skin cancer positive for BRAF V600 mutation in the EU.  The medicine has also been approved in the US for the same indication after it was shown to improve survival in this specific patient population. Similar to the US approval,