Nov. 7, 2014, 1:53 AM
- Salix Pharmaceuticals (NASDAQ:SLXP) -38.3% AH after announcing an accounting revision that showed sales of its drugs not as strong as Wall Street's expectations. The changes were accompanied by the resignation of CFO Adam Derbyshire.
- The accounting issue also played a role in scuttling a potential takeover from Allergan (NYSE:AGN) earlier this year, WSJ reports.
- Salix lowered its earnings guidance for the year, and now expects 2014 net income of $400M, or $5.20 per share, down from earlier estimates of $475M, or $6.16 per share.
Nov. 6, 2014, 5:36 PM
Nov. 6, 2014, 4:51 PM| 2 Comments
Nov. 4, 2014, 9:53 AM
- Salix Pharmaceuticals (SLXP -0.3%) launches Ruconest (C1 Esterase Inhibitor [Recombinant]) 50 IU/Kg in the U.S. for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). The FDA approved the product in July.
- Ruconest is manufactured by Pharming Group NV (OTC:PHUGF) in the Netherlands. Salix has an exclusive license to commercialize it in North America.
- Previously: Ruconest cleared in the U.S.
Oct. 23, 2014, 12:12 PM
Oct. 22, 2014, 11:31 AM
- The European Commission approves privately-held Switzerland-based Ferring Pharmaceuticals' Cortiment (budesonide) for the induction of remission in patients with active mild-to-moderate ulcerative colitis. Budesonide is a locally acting glucocorticosteroid.
- Ferring licensed Cortiment from Cosmo Pharmaceuticals SpA for the EU, Asia (ex-Japan), Australia, Canada, Latin America and Africa. The product is sold under the brand name Uceris in the U.S. by Salix Pharmaceuticals (SLXP -0.2%).
- UC-related tickers: (NASDAQ:VBLX) (RCPT)(OTCPK:TKPHF)(OTCPK:TKPYY +0.2%)(ATHX +2.3%)(SHPG +1.3%)(PFE +0.7%)(ABT -0.4%)(ABBV +1.2%)(CNDO +1.1%)(JNJ +1%)(SGYP -3.2%)
Oct. 21, 2014, 10:11 AM
- At the American College of Gastroenterology Annual Scientific Meeting, Synergy Pharmaceuticals (SGYP +6.6%) presented data from a 423-patient Phase 2b dose-ranging study assessing the safety and efficacy of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
- Patients taking 3.0 mg and 9.0 mg plecanatide showed statistically significant improvement in Overall Responder rate (41.9% and 40%, respectively vs. 24.7% for placebo), a secondary analysis in the study and the endpoint required for FDA approval for the IBS-C indication.
- The primary efficacy endpoint was the change from baseline in the mean number of complete spontaneous bowel movements (CSBMs) per week over the 12-week treatment period. Secondary endpoints included abdominal pain intensity, stool consistency, Overall Responder %, abdominal pain responder %, stool consistency as measured by the Bristol Stool Form Scale, and abdominal pain intensity measured on a scale from 0 - 10. An Overall Responder was a patient that fulfilled both >30% reduction in worst abdominal pain and an increase of at least one CSBM from baseline in the same week for at least 50% of the weeks.
- The company expects to initiate a Phase 3 trial for plecanatide in IBS-C this quarter.
- IBS-related tickers: (ARDX +3.9%)(ACT +1.4%)(IRWD +0.8%)(SLXP -0.3%)(FURX -1.1%)(LXRX +0.8%)
Oct. 16, 2014, 9:52 AM
- In conjunction with development partner Actavis (ACT -0.5%), Ironwood Pharmaceuticals (IRWD -0.7%) initiates a Phase 2 clinical trial (~240 patients) to assess the safety and efficacy of linaclotide for the treatment of adults with opioid-induced constipation (OIC). Data is expected in 2H 2015.
- Linaclotide is currently FDA-approved for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation.
- OIC-related tickers: (SLXP -0.6%)(PGNX +1.9%)(NKTR -0.5%)(AZN -2%)(CBST +0.1%)(SGYP +0.7%)(SCMP -0.3%)
Oct. 8, 2014, 8:54 AM
- The FDA approves Salix Pharmaceuticals' (NASDAQ:SLXP) Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from and anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently-approved therapies which can be ineffective due to insufficient distribution of active drug to the distal colon.
- On September 15, 2014 the FDA tentatively approved Uceris pending the resolution of patent issues.
Oct. 6, 2014, 5:20 PM
- The FDA's approval of Relistor (methylnaltrexone bromide) for OIC triggers a $40M milestone payment to Progenics Pharmaceuticals (PGNX -5.3%) from worldwide collaboration partner Salix Pharmaceuticals (SLXP -3.6%).
- Under the terms of their 2011 agreement, Progenics is entitled to receive up to $50M upon the regulatory clearance of an oral Relistor product in the U.S., up to $200M in commercial milestones, tiered royalties from 15 - 19% and 60% of revenues received by Salix from ex-U.S. sublicensees of Relistor.
Oct. 3, 2014, 9:10 AM
Oct. 3, 2014, 3:07 AM
- Salix (NASDAQ:SLXP) and Cosmo Pharmaceuticals have ended their $2.7B merger agreement, citing a "changed political environment".
- In July, Salix had announced it would merge with Cosmo's Irish subsidiary under a tax-inversion, although recent "inversion" legislation from the U.S. Treasury seems to have been effective in curbing the deal.
- SLXP +4.6% AH
Oct. 2, 2014, 6:16 PM
- Bloomberg reports Salix (NASDAQ:SLXP) is now in talks to sell itself to Actavis (NYSE:ACT), and that M&A talks with Allergan (NYSE:AGN) have faded.
- A tangled web: The WSJ previously reported Allergan was in "advanced talks" to buy Salix after turning down Actavis. Since then, speculation has grown Actavis will bid for Salix.
- SLXP +3.9% AH.
Sep. 29, 2014, 6:07 PM
- Following a successful Phase 3 trial, the FDA has approved Relistor for "the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain."
- Salix (NASDAQ:SLXP) will sell Relistor under a license from developer Progenics (NASDAQ:PGNX). Many expected FDA approval to arrive following a favorable July ruling.
- PGNX +3.4% AH.
- Related tickers: (AZN)(CBST +0.9%)(SGYP -3.4%)(NKTR -0.9%)
Sep. 28, 2014, 6:44 AM
- Another Allergan (NYSE:AGN) investor has spoken out against the company's pursuit of a costly purchase to fend off Valeant's (NYSE:VRX) $54B takeover bid.
- Jackson Square, the eighth largest investor in Allergan, now joins T. Rowe Price (NASDAQ:TROW), announcing its dissatisfaction with the newly proposed acquisition.
- This past week, Allergan was reported to be "in advanced talks" to buy Salix (NASDAQ:SLXP) in an all-cash deal after turning down an offer from Actavis (NYSE:ACT).
- “We appreciate the perspectives of our stockholders,” Allergan says in an e-mailed statement. “Allergan’s Board remains confident in the company’s ability to deliver significantly more value than Valeant’s grossly inadequate offer.”
Sep. 26, 2014, 8:35 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Nektar Therapeutics' (NASDAQ:NKTR) Moventig (naloxegol) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives.
- Moventig is a peripherally-acting mu-opioid receptor antagonist (PAMORA). The once-daily tablet blocks the binding of opioids to opioid receptors in tissues such as the gastrointestinal tract.
- The drug candidate is based on Nektar Therapeutics' (NKTR) oral small molecule polymer conjugate technology which AstraZeneca (NYSE:AZN) licensed in 2009. It was cleared for sale in the U.S. on September 16 under the name Movantik. AstraZeneca is responsible for commercialization worldwide.
- Under the terms of the license agreement, Nektar is eligible to receive up to $235M in aggregate regulatory and launch milestones, tiered sales-related milestones up to $375M and double-digit royalties on net global sales.
- Related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
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