Date: 2014-07-21
Type of information: Product launch
Product name: Sitavir® (Europe) - Sitavig® (USA)
Compound: acyclovir Lauriad™
Therapeutic area: Infectious diseases
Action mechanism:
Company: BioAlliance Pharma (France)
Disease: recurrent orofacial herpes
Latest news:
- • On July 21, 2014, Bioalliance Pharma announced the launch of f Sitavig® (acyclovir Lauriad®) in the United States by its commercial partner, Innocutis Holdings. A few weeks after the execution of a licensing agreement between the two companies, Innocutis has begun the promotion of Sitavig® in the U.S. for the treatment of labial herpes to dermatologists and top tier general practitioners.
- • On March 19, 2014, BioAlliance Pharma announced that it has received a positive opinion from the Health Authorities in France and Germany for the Market Authorization of the drug. Regarding Europe, Sitavig® had already been registered in 8 countries through a decentralized procedure successfully achieved in December 2012. As its registration strategy, the Company had filed in these countries first to ensure optimized registration timelines, and then filed a mutual recognition procedure in France and Germany, which are two major European countries with the greatest commercial potential in the European herpes labialis market. This second procedure is now finalized and both Health Authorities have issued a positive opinion for the registration of Sitavig®.
- • On April 15, 2013, BioAlliance Pharma has announced the receipt of marketing authorization from the FDA for Sitavig® in the treatment of recurring Herpes labialis. After Loramy ®, registered in 26 countries including the United States, BioAlliance Pharma for the second time has successfully passed the FDA review.
- • On December 20, 2012, BioAlliance Pharma has announced the approval of Sitavig®(acyclovir Lauriad) for the treatment of recurrent labial herpes in 8 European countries (Sweden, United Kingdom, Spain, Italy, Denmark, Finland, Norway). The decentralized procedure, with Sweden as Reference Member State, ended with a positive opinion for these first 8 countries. Each country will now issue a national marketing authorization in the coming weeks. Besides, BioAlliance Pharma plans to pursue the submission of the registration dossier in other European countries as soon as the first quarter of 2013. The evaluation by the Agencies should then last 4 to 6 months.
- • On May 29, 2012, BioAlliance Pharma announced the receivability of Sitavig® (Sitavir® in Europe) US registration dossier from the FDA for the treatment of recurrent orofacial herpes. The registration dossier, submitted to the FDA first quarter 2012, is based on the results of the pivotal phase III clinical trial conducted in 775 patients. In this trial, one single application of Sitavig®50mg significantly reduced the occurrence of vesicular lesions and crusts, their time to healing and the severity of symptoms. Moreover, a 9-month follow-up showed that Sitavig® had an effect on the long term, delaying the time to occurrence of the following herpes episode.
Patents:
- • On July 21, 2014, BioAlliance Pharma announced that the company was recently granted a new U.S. patent covering Sitavig® and strengthening its U.S. protection. This patent completes a patent portfolio of 3 patents already issued and other pending applications, and confers a commercial exclusivity on Sitavig® until December 2029.
- • On July 10, 2013, BioAlliance Pharma has announced it was granted two patents by the American and Japanese Offices protecting Sitavig® (acyclovir for the treatment of labial herpes). In addition to the first Japanese patent protecting the mucoadhesive tablet, and further to the patent protections obtained for Europe, the US and China, this grant is the first one specific to Sitavig® in Japan for the treatment of labial herpes. Sitavig is now protected until 2027 in Japan.
- • On July 26, 2012, BioAlliance Pharma has announced the grant of US patent covering Sitavig®. This patent covers the Sitavig® tablet, its manufacturing process and its application for the treatment of recurrent labial herpes until 2027. BioAlliance Pharma has conceived and developed Sitavig® (mucoadhesive tablet containing acyclovir) for the treatment of labial herpes in immunocompetent patients presenting more than 4 episodes a year. Sitavig® is an innovative mucoadhesive tablet to apply to the upper gum, allowing the delivery of very high concentrations of the active ingredient at the site of herpes infection, thus with a reinforced profile of efficacy.
- After the grant of a patent for Sitavig® in Europe and in major Asian territories, this US grant gives BioAlliance a worldwide protection for its product. BioAlliance Pharma has already concluded a first license agreement with Teva for Israel.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2013-04-15
UE authorization: 2012-12-20
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
