CROSSJECT 2015 half-year results
& progress update
Partnership contract
for ZENEO® Methotrexate in India
Chenôve, France, 14 September 2015, 5.45pm - CROSSJECT (ISIN: FR0011716265; Ticker: ALCJ), the developer of ZENEO®, a needle-free drug injection device, provides an update of its activity since the start of the year and publishes its results for the first half of 2015 ended 30 June.
The Supervisory Board, chaired by Philippe Monnot, met on 10 September 2015 to review the financial statements for the first half of 2015, as approved by the Executive Board.
- Signature of a partnership agreement for® Methotrexate in India
- Launch of a clinical study to demonstrate Zeneo® Adrenaline's ability to deliver an intramuscular injection
- Financing for Zeneo® L15 secured through a Eurostars programmer within an orphan indication
- Supply chain finalization by the end of 2015
- Financial resources remain sound: €10 million
Patrick Alexandre, Chairman and founder of CROSSJECT, said, "In line with its strategy and targets, Crossject has continued to develop its portfolio of super-generic drugs over the half year. Crossject has signed a partnership agreement with Sayre Therapeutics for the marketing of Zeneo® Methotrexate in India and should file the application for the European marketing authorization in early 2016. Two bioequivalence studies are scheduled to take place in the coming months. In parallel, the entire supply chain will be fully operational shortly and its certification should take place by the end of the financial year. We are therefore deploying our road map and are confident in our ability to position Crossject as a laboratory capable of developing its own portfolio of proprietary medicines in order to establish Zeneo®, its innovative and needle-free injection system, as a standard for emergency situations and for the majority of chronic treatments."
First half highlights
Over the course of the half year, Crossject continued to develop its portfolio of products combining established drugs with Zeneo®, a needle-free device particularly suitable for emergencies and for most chronic treatments.
- Zeneo® Methotrexate (rheumatoid polyarthritis)
Building on the success of the Zeneo® Methotrexate bioequivalence study conducted during the second half of 2014, Crossject intends to apply for marketing authorization in Europe at the start of 2016.
Crossject has also signed a collaboration and marketing agreement for ZENEO® Methotrexate in India and other countries from the Indian subcontinent (press release published on 14 September 2015). This agreement provides for value sharing in line with Crossject's ambitions through the payment of royalties, which over time could reach 40% of the sales generated by the partner, and minimum volume marketing/promotion investment commitments. The marketing authorization application for the region is planned for early 2017.
Zeneo® Methotrexate already has a partnership agreement in place for its marketing in France.
The human factors study is ongoing in the United States, where Zeneo® Methotrexate is currently the subject of a Pre-IND n° 122,189 procedure.
- Zeneo® Adrenaline (allergic/anaphylactic shock)
Zeneo® Adrenaline remains particularly well positioned with regard to establishing itself as an indispensable product for allergic shock. The review initiated by the European Medicines Agency (EMA), on the efficacy of the needle based injector pens currently on the market, is ongoing. Crossject is currently conducting an MRI study aimed at demonstrating Zeneo® Adrenaline's ability to deliver an intramuscular injection, in accordance with the European Medicine Agency's expectations.
Zeneo® Adrenaline has a worldwide partnership agreement in place.
- Zeneo® Sumatriptan (facial algia and acute migraine)
Crossject's strategy is focused on patients suffering from severe acute migraines and facial algia, two conditions whose attacks can only be treated with Sumatriptan.
The CRO was selected in June 2015 and the Zeneo® Sumatriptan bioequivalence study should therefore be launched during the second half of 2015, in parallel with stability tests for Sumatriptan incorporated into Zeneo®.
In parallel, Crossject is in discussions with the FDA regarding the development of Zeneo® Sumatriptan in the United States as part of a Pre-IND process, reference 127,044.
- A new super-generic drug: Zeneo® "L15" (drug and indication both confidential)
Zeneo® "L15" is dedicated to emergency situations where an intramuscular injection is required. Crossject is developing this high added value product. Its development is receiving the support of a Eurostars program worth €1.3 million, €600,000 of which is dedicated to Crossject.
Zeneo® "L15" could benefit from "orphan status" in Europe and the United States, the necessary steps being underway. In the event that such status is obtained, commercialization can begin in certain cases even before marketing authorization is received, within the framework of temporary authorizations for use (TAU) for which the price is freely set by the manufacturer. Obtaining orphan status is not however a prerequisite for the development and marketing of Zeneo ® L15.
As such, Crossject has already selected Parexel as CRO (Clinical Research Organization) to lead the bioequivalence study of this drug, which should take place in six months' time.
- Strengthening intellectual property
Lastly, Crossject has applied for five new patents, linked with an optimization of Zeneo® as part of its industrialization (mechanical aspects, sealing, trigger device, etc.). They will provide greater robustness combined with lower manufacturing costs and will strengthen the protection of Zeneo® at international level until 2035.
- Finalization of the supply chain underway
Crossject is currently finalizing the remaining components of its supply chain. It should therefore be operational by the end of the year, as previously announced.
A sound financial position reflecting the progress of projects
At 30 June 2015, Crossject's cash and cash equivalents totaled €6.5 million as against €10.9 million at 31 December 2014. Resources available at 30 June stood at €10 million taking into account receivables and funding available.
Operating revenue was €1.2 million compared with €0.8 million at 30 June 2014. The Company's total operating expenses for the first half of 2015 totaled €5.0 million against €3.2 million for the same period of 2014.
Over the first six months of 2015, operating losses stood at €3.8 million as against €2.4 million for the first half of 2014. Net losses were €3.6 million compared with €2.1 million for the same period of the previous financial year. This change can be explained by Crossject's growth, the preparation of bioequivalence studies, the strengthening of teams, the rollout of the supply chain and following up the necessary work for the market authorization applications (Europe and US) for the four super-generic drugs.
The full "Half-Year Financial Report" will be available on September 30th 2015 after close of trading on the Company's website www.crossject.com:
http://www.crossject.com/.
Contacts
| Crossject |
Patrick Alexandre / Timothée Muller
info@crossject.com
Citigate Dewe Rogerson
Laurence Bault /Lucie Larguier
+33 (0)1 53 32 84 78 / 84 75
laurence.bault@citigate.fr
lucie.larguier@citigate.fr
About Crossject · www.crossject.com
Crossject is using its world-leading needle-free injection system, ZENEO(TM) to develop an attractive pipeline of high-value SUPERGENERICS or New Therapeutics Entities. These needle-free products, which are based on well-known injectable drugs (chemicals & biologics), are designed to enhance patient safety, compliance and comfort.
Crossject's needle-free, pre-filled, single-use ZENEO (TM) injection systems are unique in that they can be tailored to deliver drugs intradermally, subcutaneously and intramuscularly. This means that ZENEO(TM) can allow a wide range of drugs and vaccines for a broad range of indications to be developed and approved in a very short period. Outside its own portfolio of SUPERGENERICS, Crossject anticipates partnering ZENEO with other pharma/biotech looking to improve the life cycle management of their key drugs or biologics.
Crossject is listed on Alternext Paris (Mnemo : ALCJ, ISIN: FR0011716265)
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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: CROSSJECT via Globenewswire
