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)
Sep. 24, 2014, 12:16 PM| Comment!
Sep. 23, 2014, 12:31 PM| Comment!
Sep. 23, 2014, 10:23 AM
- In a letter to Allergan's (AGN +2.1%) board, Pershing Square's Bill Ackman says he'll sue the company for breaching its fiduciary duties if it follows through on its rumored acquisition of Salix Pharmaceuticals (SLXP +5.5%) without a shareholder vote. He claims that its attempts at acquisitions are desperate actions to thwart Valeant's (VRX +0.7%) takeover bid.
Sep. 23, 2014, 9:10 AM
Sep. 23, 2014, 7:51 AM
Sep. 23, 2014, 3:45 AM
- Under Treasury Secretary Jack Lew’s crackdown on inversions, the Treasury Department announced new tax rules late yesterday to deter U.S. companies from moving their domicile to countries with lower tax rates.
- The tax changes make it harder for companies to complete overseas mergers, and should they choose to invert, companies will face a hard time using the cash accumulated abroad.
- The new rules are effective immediately and apply to all deals that have not closed by yesterday.
- Related M&A: MDT, COV, SLXP, MYL, CQB, OTC:FYFFF,BKW, THI
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