Categories: Approval

Dr. Reddy’s Laboratories announces entering into a definitive agreement to sell its neurology branded products to Upsher-Smith Laboratories, LLC

Hyderabad, June 14, 2019: Dr. Reddy’s Laboratories Limited (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announces that it has entered into a definitive asset purchase agreement with Upsher-Smith Laboratories, LLC (Upsher-Smith), pursuant to which Dr. Reddy’s would sell its US and select territory rights for ZEMBRACE® SYMTOUCH® (sumatriptan injection) 3 mg and TOSYMRATM (sumatriptan nasal spray) 10 mg, (formerly referred to as “DFN-02”), which are commercialized through its wholly owned subsidiary, Promius Pharma, LLC.

Under the agreement, Dr.Reddy’s will receive U.S.$70 million as upfront consideration, U.S.$40.5 million in near term milestones and additional financial considerations including, existing contractual obligation and inventory.  Subsequently, Dr. Reddy’s will receive sales based royalties on a quarterly basis.

The closing of the transaction is subject to various customary closing conditions including antitrust review under Hart-Scott-Rodino Act.

“This is a testament to our strong R&D capabilities, and delivering solutions to unmet needs of patients. In a short time, we created a well-recognized migraine specialty business in the US and we look forward to our partnership with Upsher-Smith” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories Limited.

“Tosymra and Zembrace were designed and developed with the goal of addressing unmet needs of large but discrete segments of patients suffering from episodic migraine who need options other than their current therapies.  We are excited to partner with Upsher-Smith which has established a strong presence in neurology” said Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products and Head, Promius Pharma.

Important Patient Safety Information for Zembrace SymTouch (sumatriptan injection) 3 mg and TOSYMRA (sumatriptan nasal spray) 10 mg.

Zembrace SymTouch and TOSYMRA can cause serious side effects, including: heart attack and other heart problems, which may lead to death.

Do not use Zembrace SymTouch and TOSYMRA if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your healthcare provider
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your healthcare provider if you are not sure if your medicine is listed above
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor.  Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the ingredients in Zembrace SymTouch and TOSYMRA.

You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/Safety/MedWatch

Please see Full Prescribing Information for Zembrace SymTouch and TOSYMRA.

For more information, please visit www.zembrace.com and www.mytosymra.com

Corporate Comm India(CCI Newswire)

The Pharma Times News Bureau

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