Date: 2012-09-27
Type of information: Product acquisition
Compound: Huntexil® (pridopidine / ACR16)
Company: NeuroSearch (Denmark) Teva Pharmaceutical (Israel)
Therapeutic area: Genetic diseases - Neurodegenerative diseases - Rare diseases
Type agreement: product acquisition
Action mechanism:
- Huntexil® (pridopidine / ACR16) is an oral small molecule dopamine D2 stabilizer being developed for the symptomatic treatment of non-choreic motor disorders, including for Huntington disease.
Disease: Huntington disease
Details:
- • On September 27, 2012, NeuroSearch and Teva Pharmaceutical Industries have concluded an Asset Transfer Agreement to purchase all rights, assets and obligations relating to Huntexil® (pridopidine / ACR16), a drug candidate being developed for the symptomatic treatment of hand movement, balance and gait disturbances in Huntington disease (HD). The agreement is conditional upon NeuroSearch shareholder approval as well as a number of standard conditions. The agreement is not subject to approval by any public authorities, including merger control authorities.
- Provided that NeuroSearch shareholders approve the agreement with Teva, the immediate focus of NeuroSearch will be to transfer the Huntexil® project to Teva in a diligent manner according to the agreement. In parallel, the Board of Directors and the Executive Management will evaluate the strategic options for NeuroSearch, including value maximisation of the assets that remain within the company. NeuroSearch expects to conclude and execute upon this evaluation early 2013.
- Teva intends to design and complete new clinical studies of Huntexil® to assess its potential for symptomatic relief of HD. Advanced-stage clinical studies of Huntexil® conducted in the US, EU and Canada in patients with HD demonstrated a significant treatment effect on Total Motor Score [TMS]), but failed to meet the primary endpoint (Modified Total Motor score [mTMS]). Data from the clinical studies were presented to the FDA and EMA in the first half of 2011, but were found insufficient to file for marketing approval.
Financial terms:
- Under the agreement, Teva will pay to NeuroSearch approximately $26 million (DKK 150 million - € 20.1 million) over a period of at least six months. Regulatory and commercialization milestone payments may result in additional funding for NeuroSearch with a total value of up to DKK 55 million (€7.3 million).
The main terms and conditions of the agreement are as follows:
• The cash purchase price is DKK 149.5 million. Of this, DKK 28.7 million will be placed in escrow for a minimum period of six months after closing, to be released upon satisfactory project transfer of Huntexil® from NeuroSearch to Teva.
• In addition, NeuroSearch is entitled to potential milestones of up to DKK 55.1 million relating to:
First registration application for Huntexil® DKK 22.0 million
First marketing approval of Huntexil® in an EU or EFTA country DKK 16.5 million
First marketing approval of Huntexil® outside the EU or EFTA DKK 16.5 million
• NeuroSearch is to ensure successful project transfer of Huntexil® to Teva in a period of six months after closing of the agreement. A payment to NeuroSearch of DKK 17.2 million to cover related expenses is included in the cash purchase price.
• NeuroSearch is to pay DKK 4.3 million to Teva in the event that NeuroSearch shareholders do not approve the agreement and DKK 14.4 million is to be paid in the event that the shareholders do not approve the agreement due to a superior offer from a third party.
Latest news:
- • On September 8, 2018, Neurosearch announced that the company has been informed that Teva has completed a definitive agreement relating to the sale and transfer of Teva's right in and to Pridopidine with effect from 9 September 2018, and that NeuroSearch therefore pursuant to the Agreement will receive a cash payment of $450,000. As a result of NeuroSearch receiving the cash payment of $450,000, NeuroSearch changes the financial outlook to 2018 from a loss of approximately DKK 5 million to a loss of approximately DKK 2-3 million.
- • On May 16, 2018, NeuroSearch has entered into an agreement with, among others, Teva Pharmaceutical, to release Teva from all outstanding obligations pursuant to the agreement from 2012 concerning the transfer of NeuroSearch's rights in and to Pridopidine. According to the agreement now entered into, in the event that Teva prior to 31 October 2018 enters into an agreement with an identified third party relating to the sale and transfer of Teva's rights in and to Pridopidine, then NeuroSearch will receive a cash payment of USD 450,000. This agreement is in connection with Teva’s decision not to develop Pridopidine further following the failure by Pridopidine to meet its primary endpoints in Huntington’s Disease in a Phase II trial conducted by Teva, and potential interest in the asset by an identified third party. Provided the agreement is finally completed, NeuroSearch's financial expectations for 2018 will be amended from a loss of DKK 3.5-4.5 million to a loss of DKK 0.8-1.8 million.
- • On October 25, 2012, NeuroSearch has announced that the company has closed the asset transfer agreement with Teva Pharmaceutical Industries concerning the sale of the Huntexil® project to Teva . The agreement was approved by NeuroSearch shareholders at the Extraordinary General Meeting, which was held on 23 October 2012. NeuroSearch has received DKK 120.8 million in cash, and in addition Teva has placed DKK 28.7 million in escrow which will be released upon satisfactory transfer of the Huntexil® project, however, not earlier than six months from today.
- For a period of up to six months, NeuroSearch will ensure the diligent transfer of the Huntexil® project to Teva. In parallel, the Board of Directors and the Executive Management will evaluate strategic options for NeuroSearch, including value maximisation of the assets that remain within the company. NeuroSearch expects to be able to conclude and execute upon this evaluation early 2013.
- • On October 23, 2012, NeuroSearch has announced that the sale of Huntexil® to Teva Pharmaceutical Industries Ltd. through the fully owned affiliate Ivax International GmbH was approved by the general meeting. The obtained approval from NeuroSearch shareholders is one of several conditions for the sale of Huntexil®. NeuroSearch will inform the market as soon as the transaction with Teva has been fully completed.
Is general: Yes
