Astellas received approval to market Kiklin in Japan

Astellas announced that the company has received approval to market Kiklin (ASP1585 or bixalomar) for the treatment of hyperphosphatemia in patients on dialysis with chronic kidney disease in Japan.

Bixalomar is an amine-functional polymers which can decrease the concentration of phosphorus in the serum by binding to phosphate in the gastrointestinal tract which leads to an inhibition of absorption of phosphate into the body.

Astellas and Ilypsa (now owned by Amgen) has

AstraZeneca won patent infringement case

Recently, the  US District Court has ruled the patent protecting Seroquel XR formulation is valid and Anchen Pharmaceuticals, Osmotica, Torrent Pharmaceuticals, Torrent Pharma Inc, Mylan Pharmaceuticals and Mylan Inc have infringed the patent. Based on the record, the patent protecting Seroquel XR is set to expire in 2017.

AstraZeneca has previously settled its patent infringement

Seaside Therapeutics announced new issued patent for STX209

Seaside Therapeutics announced that the US Patent and Trademark Office has issued the US patent No 8,143,311 titled "methods of Treating Fragile X Syndrome and Autism" for the company's lead product STX209.

STX209 is an oral selective gamma-aminobutyric acid-B receptor agonist.  It's currently being studied in the phase 2b study in patients with autism spectrum disorders and is currently being investigated in phase 3 studies for the treatment of fragile X syndrome.

Ultragenyx received orphan drug designation for its sialic acid agent

Ultragenyx announced that the European Medicines Agency has granted orphan drug designation for the company's sialic acid for the treatment of hereditary inclusion body myopathy and recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type 7 (MPS 7).

The company's UX001 is the extended release formulation of sialic acid that has been intended to be used as a substrate replacement therapy for HIBM, a severe , neuromuscular

Allena acquired hyperoxaluria from Althea

Allena Pharmaceuticals announced that it has entered into an agreement to acquire exclusive worldwide rights to Althea's broad hyperoxaluria portfolio products including product patents, regulatory information and development data that are related to oxalate degrading enzymes.  The acquisition will allow Allena having access to the supportive phase I clinical data involving 58 healthy volunteers conducted by Altus whose ALTU 237 was acquired by Althea.

Althea Technologies is a contract manufacturing organization that can provide development and manufacturing services to other companies.

Bausch & Lomb to acquire Ista

Move over Valeant! Bausch and Lomb has signed a definitive agreement to acquire ISTA for $9.1 per share in cash. This constitutes to approximately $500 M.

The transaction has been approved by the boards of directors from both companies unanimously and is expected to close in the second quarter of 2012.

Bausch & Lomb intends to finance the acquisition with a combination of both cash and the proceeds of a $350M incremental term loan facility. 

Not too long ago, Valeant has proposed to acquire Ista for $6.5 per share. Ista deemed the price was inadequate and has rejected the offer. Consequently, Valeant has withdrawn its offer.

Goldman, Sachs & Co served as financial advisor to Bausch and Lomb in the transaction while Cleary Gottlie Steen and Hamilton LLP served as its legal counsel.  On Ista side, Greenhil & co served as the company's financial advisor and Stradling Yocca Carlson & Rauth and WilmerHale LLP serve as its legal advisors.

Ista has generated revenues of $160M in 2011. 

Omontys of Affymax and Takeda has been approved in the US

Takeda and Affymax have jointly announced that the FDA has approved Omontys (peginesatide) injection for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. Omontys is an erythropoiesis-stimulating agent that can be taken once a month.

The companies have conducted two randomized, controlled, open-label, phase III studies (EMERALD 1 and 2) investigating the safety and efficacy of Omontys given once a month to epoetin dosed between one to three times a week to maintain the level of hemoglobin in

The European Medicines Agency accepts the Marketing Authorization Application submitted for lorcaserin

Arena announced that the European Medicines Agency has accepted the Marketing Authorization Application that the company submitted for lorcaserin for weight control, including weight loss and maintenance of weight loss in patients who are obese (BMI of 30 or higher) or patients who are overweight (BMI of 27 or higher) and have at least

The FDA approved Teva's beclomethasone nasal spray

Teva announced that the FDA has approved the company's New Drug Application submitted for QNASLTM (beclomethasone dipropionate) for the treatment of allergic rhinitis.

The company expects to launch the product in April 2012.

QNASL Nasal Aerosol is a new and dry nasal aerosol corticosteroid that can be used to treat seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older.

QNASL can be used once a day and is contained in a pressurized, HFA-propelled nonaqueous aerosol.

The main ingredient in QNASL is beclomethasone which is a synthetic corticosteroid that can be used to reduce inflammation in the body.

Each QNASL canister can deliver 120 actuation with each actuation containing 80 mcg of beclomethasone dipropionate.  The maximum recommended dose is 320 mcg per day.  

The most commonly observed side effects were nasal discomfort, nosebleeds, and headache

MAP to host a conference call after receiving a complete response letter from the FDA

MAP Pharmaceutical announced that it has received a complete response letter from the FDA in regard to the new drug application submitted for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults.

The FDA stated in the letter saying that it can't approve the compound at its current status. The following issues have discussed:chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer.

The FDA did not mention about additional clinical data are required. Neither did the FDA talk about any clinical safety and efficacy issues.

MAP to host a conference call on Tuesday March 27, 2012 at 8:00 AM Eastern Time to discuss the the complete response letter.

To participate in the conference call:
- Domestic callers:877-291-1367
- International callers:253-237-1128

The webcast will also be available for viewing on the company website.

Takeda and Ajinomoto submitted marketing application for risedronate in Japan

Takeda and Ajinomoto Pharmaceuticals jointly announced the submission of the marketing applications for a once-monthly formulation of risedronate sodium hydrate for the treatment of osteoporosis to the Japanese Ministry of Health, Labour and Welfare.

Risedronate belongs to a therapeutic class called

Impax signed a collaborative agreement with Tolmar

Impax Laboratories has entered into a collaborative multiproduct agreement with Tolmar Inc. Under the agreement, the companies will work to develop, supply and distribute alternative dosage forms of different products.

Based on the press release, the target products had over

Valeant to acquire Natur Produkt

Valeant announced that it has entered into an agreement to acquire Natur Produkt International for approximately $180M. Natur Produkt is a specialty pharmaceutical company based in Russia. The company has a significant market for over-the-counter products under the umbrella brand Natur Produkt. Some of the key brands are AntiGrippin, Anti Angin, Sage and Eucaplytus MA brand names.

The company had $64M in revenue in 2011 and is expected to have double digit growth in 2012.