Lupin (LPC) has announced the acquisition of Symbiomix Therapeutics for a cash consideration of $150m, including $50m upfront and other time based payments. In addition, there are sales-based contingent payments. The transaction was closed on October 11 2017.
Symbiomix has no sales, and is working on the innovative branded franchise Solosec. In March 2017, Solosec NDA was submitted with the USFDA, and on September 15, 2017, the USFDA approved Solosec oral granules for the treatment of Bacterial Vaginosis (BV) in adult women. LPC expects Solosec to be commercially available by mid-2018. Solosec is the first and only single-dose oral treatment approved for BV. The company believes that Solosec is eligible for at least 10 years of exclusivity in the US.
According to the Centre for Disease Control and Prevention (CDC), Metronidazole or Clindamycin cream is the recommended regimen. Tinidazole is the alternative regimen to treat BV. Metronidazole requires twice-a-day dosage for seven days for a total administration of seven grams of drug v/s single-dose requirement for Solosec. A study shows that adherence to Metronidazole for the treatment of BV has been 50%. Poor adherence due to the length of the regimen may lead to treatment failures, recurrent disease, and more rapid development of resistant microorganisms. However, Tinidazole 2g can be consumed once for two days.
Apart from existing drugs like Metronidazole, Clindamycin and Tinidazole, VivaGel could be the latest and only branded competition to Solosec. Start Pharma successfully completed Phase-3 studies for VivaGel in August 2017. Like Solosec, the FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for VivaGel BV (for both BV indications). Star Pharma also expects to launch this in 2018. The key factor is that VivaGel is not an antibiotic, and an NDA will be filed for two separate BV indications – BV treatment and prevention of rBV (more than 50% of women treated for BV have a recurrence within 12 months). Currently, there is a treatment that claims prevention of BV (including Solosec). However, in terms of dosage, Solosec will have an advantage, as VivaGel is a seven-day treatment.