1) VPHM Cinryze
The first quarter 2013 U.S. Cinryze net sales which grew by 44 percent over the first quarter of 2012 to $97 million, including approximately $91 million of patient demand. The balance represented additional inventory in the channel.
2) Icatibant (Firazyr) is a synthetic bradykinin B2 receptor antagonist,
3) Kallikrein inhibitor (US only) — Ecallantide (Kalbitor, Dyax Corp) is a genetically engineered recombinant plasma kallikrein inhibitor
Patients in whom episodes occur at least once a month or who are at high risk of developing laryngeal edema require long-term prophylaxis. There are now several phase III clinical trials recently published in HAE prophylaxis and therapy and these have led to the licensing of pdC1INH (Berinert®, CSL Behring; Cinryze®, ViroPharma; Cetor-n®, Sanquin) in many parts of the world; bradykinin receptor antagonist (Icatibant, Firazyr®, Jerini/Shire) in Europe; kallikrein inhibitor(Ecallantide, Kalbitor®, Dyax) in the United States; and recombinant C1-INH replacement therapy (rhC1INH; conestat alfa; Rhucin®, Pharming) in Europe. Tranexamic acid has been showed to be relatively ineffective therapy. Danazol prophylaxis remains an option but therapeutic agents are now being used more for prophylaxis because of danazol adverse events.  For patients requiring long-term prophylaxis, home therapy which allows patients to self-administer product, is considered an integral part of allowing patients a normal quality of life.
Cost of first-line therapies — All first-line therapies for acute attacks of HAE are costly. In the US, the cost of one treatment with C1INHRP, ecallantide, or icatibant ran
Note: Lies by Leerink Swann , there is no such competition from Shire, Miss Alice has already covered this in detail.
Shares of specialty drugmaker Santarus (SNTS) were down 4.2% on the stock market Thursday morning after Leerink Swann downgraded the stock.
Analyst Jason Gerberry lowered his rating to market perform from outperform, noting the stock has been the top performer in specialty pharma this year and is trading at a premium. He attributed that mostly to the strong launch of bowel-disease drug Uceris earlier this year, but wrote that a recent survey of gastroenterologists suggested to him that sales will not exceed current consensus.
Gerberry also wrote that the expected launch of Ruconest next year is unlikely to unseat the dominance of Shire (SHPG) in the hereditary-angioedema space.
Santarus scores a highest-possible IBD Composite Rating of 99, but shares had already pulled back near the 50-day moving average after hitting an all-time high above 28 on Aug. 7, after hitting a 24.10 buy point in early July.
Sentiment: Strong Buy
Ruconest is out of competition with VPHM
Check out HALO news! Ph2 study cancelled by VPHM
ViroPharma Provides Update On Phase 2 Clinical Evaluation Of Subcutaneous Cinryze® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20)
EXTON, Pa., Aug. 1, 2013 /PRNewswire/ — ViroPharma Incorporated (NASDAQ: VPHM) today announced that following discussion with the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration, ViroPharma is going to discontinue this Phase 2 study. The discontinuation of the study is a precaution related to the emergence of an unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies in a number of patients with the formulation being used in this study. These antibodies have not been associated with any adverse clinical effects and are of unknown clinical significance.
Cinryze is approved in the United States as intravenous (IV) administration for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), and in Europe for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks in adolescent and adult patients with HAE
This is great. SNTS may look for prophylactic HAE indication also. Also pancreatic indication may be pursued. VPHM product is from human blood and needs careful purification. Ruconest will be cheaper. SNTS is still our little baby. We really could head to $40's+ if Ruconest gets approved. Uceris is growing nicely, already approaching the rate of $100 million per year sales on script counts
I read this on this board:
Good question. From what little I heard in various presentations they want to continue to expand current pipeline with further indications. Ruconest, they want to look at prophylaxis in addition to current acute HAE, also pncreatic indication. Cinryze (VPHM for prophylaxis), sells over $300 million per year. It is made from human source, so purification is expensive. Ruconest comes from rabbit, so much cheaper and no contamination with human disease.
For buying another company, it should be aligned with current sales force areas. Metabolic (diabetes, etc). GI (Uceris and Zegerid, and Rif MMX), and biologics (Ruconest and hopefully SAN) for imflamatory immune disorders. I have been wondering who they could take on, but anything I would say would be speculation. Partner deals are also possible. HZNP has an arthritis drug (prednisone exotic dosage form). XNPT has some interesting pipeline compounds (i don't know if SNTS would want pipeline compounds). I have to look over all the companies I follow, once again. I trust management, that is why I have the stock. They will invest wisely if it is the right one
Cost of first-line therapies — All first-line therapies for acute attacks of HAE are costly. In the US, the cost of one treatment with C1INHRP, ecallantide, or icatibant ranged from $5000 to $10,000 . The cost of one treatment with C1INHRP, rhC1INH, or icatibant in the European Union is about 1500 to 2000 euros
check uptodate dotcom
Aetna considers Cinryze experimental and investigational for the treatment of acute angioedema attacks, cerebral ischemic injury, cytokine-induced vascular leak syndrome, myocardial infarction, sepsis, and all other indications because its effectiveness for these indications has not been established.
Aetna considers Berinert experimental and investigational for prophylaxis against angioedema attacks and other indications because its effectiveness for these indications has not been established.
Aetna considers Kalbitor experimental and investigational for all other indications (e.g., reduction of blood loss during surgery) because its effectiveness for these indications has not been established.
Aetna considers Firazyr experimental and investigational for prophylaxis against angioedema attacks and other indications (e.g., acute pancreatitis, airways disease, thermal injury, drug-induced angioedema, and refractory ascites in persons with liver cirrhosis) because its effectiveness for these indications has not been established.