The European Medicines Agency accepts Salix Pharmaceuticals' (SLXP -0.3%) and partner Progenics Pharmaceuticals' (PGNX -1.9%) submission for the use of Relistor (methylnaltrexone bromide) in patients with chronic non-cancer pain. The product is currently approved as a treatment for opioid-induced constipation in advanced illness patients.
Salix Relistor revenues for 2011 - 2013 were $27M, $33.2M and $39.4M, respectively.
Progenics' royalty income for the same years was $3.046M, $4.963M and $5.895M, respectively.
San Francisco Assemblyman Tom Ammiano submits a bill to tighten the regulations governing the use of medical marijuana by adults. It would make it illegal for physicians to prescribe medical pot for patients they have not examined and bar prescriptions by doctors who have a financial stake in a pot dispensary.
The assembly Public Safety Committee passed the bill yesterday.
Somewhat controversial is the provision for the Department of Alcoholic Beverage Control to enforce the law. The California Narcotic Officers Association cites the irony in allowing an agency with regulatory responsibility over the use of recreational substances to regulate medical products. The senate version specifies the state health department as the regulator.
The bill, if passed, could lay the groundwork for a tax-and-control scheme for recreational pot use similar to Colorado and Washington.
Spectrum Pharmaceuticals' (SPPI) conditioning treatment in autologous transplants in multiple myeloma, Captisol-enabled (propylene glycol-free) Melphalan (CE Melphalan) meets its primary endpoint of determining the overall safety and toxicity profile in multiple myeloma patients receiving 200mg/m2 of CE Melphalan as myeloablative therapy prior to autologous stem cell transplantation.
Propylene glycol is associated with undesirable renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds.
A previous clinical trial established bioequivalence to the currently-available IV formulation of melphalan.
The company plans to file an NDA in Q3.
The FDA granted Orphan Drug Designation to the product for this indication.
Undeterred by a federal court smack down of his state-wide ban on Zogenix's (ZGNX) Zohydro, Governor Deval Patrick's Administration institutes restrictions on prescribing the product. Doctors will have to complete a risk assessment and pain treatment agreement before employing any opioid like Zohydro. The agreement covers drug screening, pill counts, safe storage and disposal and other safeguards against abuse.
The MA Board of Registration of Medicine approved the new requirements yesterday. Department of Public Health Commissioner Cheryl Bartlett issued an emergency order requiring physicians to use the state's Prescription Monitoring Program before prescribing Zohydro. The provides a mechanism for authorities to track where patients are receiving their medications.
Soliris is currently approved in the U.S., European Union, Japan and other countries for the treatment of paroxysmal nocturnal hemoglobinuria and atypical uremic syndrome.
The company is currently investigating the product's use for the prevention of acute antibody-mediated rejection in kidney transplants and for the prevention of delayed graft function in patients receiving deceased donor kidney transplants.
The EC's orphan drug designation applies to medical products that treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 people. Like the U.S., the product will have a period of market exclusivity in the EU upon regulatory approval for the specific indication.
If any unapproved investor purchases 10% or more of Allergan's stock, other shareholders will have the right to acquire discounted shares. The plan would prevent Ackman from significantly increasing his 9.7% stake and it would stop Valeant from taking its offer directly to shareholders.
Allergan said the plan is not designed to prevent a takeover bid that directors are in favor of; rather it "aims to provide the board with adequate time to fully assess any proposal." (PR)