Pronova BioPharma ASA: Strong Progress Towards Diversification
(Thomson Reuters ONE) -
11 May 2012, Lysaker, Norway: Pronova BioPharma announced first quarter 2012
revenues of NOK 480.9 million, up 6.5 percent compared with the first quarter
2011. EBITDA was NOK 225.1 million, representing a 26.9 percent increase over
the same period last year.
End-user demand in Pronova BioPharma's current eight largest markets, as
measured by IMS, grew 2 percent overall, resulting in moving annual total (MAT)
volumes of 1 268 tonnes. This represents USD 1.4 billion in drug sales on a MAT
basis, up 6 percent year-on-year, ensuring that Pronova BioPharma's
pharmaceutical product remains a blockbuster. Strong volume growth was seen in
Spain, Greece and France, which grew by 26, 17 and 17 percent versus the first
quarter 2011, respectively. In the US, although there has been a slight
weakening of underlying demand, marketing partner GlaxoSmithKline is launching
a direct-to-consumer marketing campaign.
At the time of the release of this report, there has not been a ruling in the
US litigation and none of the defendants have received tentative marketing
approval from the FDA, 43 months after the assumed date of Abbreviated New Drug
Application (ANDA) submissions. The Company believe that a ruling is imminent.
Furthermore, as previously communicated on 20 April 2012, Teva UK Limited has
obtained authorisation to market a generic version of a 1 gram soft capsule
omega-3 acid ethyl esther in the United Kingdom. The composition patent covering
Omacor® in most European territories expired in August 2009, and this is the
first known marketing authorisation of a generic pharmaceutical product based on
Pronova BioPharma's active pharmaceutical ingredient (API). Pronova BioPharma is
not aware of any generic launch in Europe. The Group has been preparing for the
possibility of losing exclusivity since patent expiry, and will continue to
monitor the situation as it evolves. Together with the company's commercial
partners, Pronova BioPharma will continue to prepare to reposition in a new
competitive landscape.
In the first quarter of 2012, Pronova BioPharma prepared for an expected second
quarter launch in Brazil, Argentina and India. These markets possess strong
demographic and healthcare growth trends, and represent attractive longer term
opportunities for the Group.
In addition, Pronova BioPharma has made significant progress towards developing
its consumer healthcare business for the fast-growing omega-3 consumer
healthcare market with first orders expected in May and official launch in
November. Pronova BioPharma's superior innovation power, based on its
pharmaceutical product expertise, and pure quality, producing high
concentration omega-3s with patented environmental pollutant-stripping
techniques, will help to differentiate the Company's products.
Pronova BioPharma has also made significant progress in developing its clinical
nutrition business. The Group has identified two clinical research projects in
clinical nutrition with top academic institutions in the United States.
Furthermore, in order to help define and position the offering for the clinical
nutrition markets, Pronova BioPharma has established an advisory board of global
key opinion leaders in the sector. The Company is also in commercial
discussions with potential key clinical nutrition partners.
Phase I clinical trials of the Group's leading research and development
candidate, PRC-4016, have demonstrated that the product has a high degree of
tolerability; there has been no toxicity at the dose levels tested. Pronova
BioPharma is therefore conducting further tests to evaluate PRC-4016 at higher
doses. Once these tests are completed, in Q4 2012, the Group expects to move the
product into Phase II clinical trials.
Pronova BioPharma continues to extend its manufacturing advantages. During the
period the Group made further progress towards achieving its 2014 target of
increasing manufacturing yields by 50 percent compared to 2009 levels, and is on
track to meet that goal. The Group has also made a number of technological
advancements in order to produce different omega-3 concentrates.
Pronova BioPharma maintains its outlook for 2012 with revenue and EBITDA growth.
The main risk to the outlook is loss of market exclusivity.
Pronova BioPharma's Chief Executive Officer Morten Jurs commented, "We achieved
strong financial results in the first quarter of 2012. Furthermore, since the
start of the year we have again made significant progress towards our strategic
objectives of strengthening and diversifying the business. For our
pharmaceutical product, we are preparing launches in developing markets and
have extended our manufacturing advantages. We also continue to make strong
progress towards diversification, having further developed our consumer
healthcare and clinical nutrition businesses, and seen encouraging safety
signals in our R&D trials."
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
Report Q1 12:
http://hugin.info/137506/R/1611142/512358.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Pronova BioPharma ASA via Thomson Reuters ONE
[HUG#1611142]
Unternehmensinformation / Kurzprofil:
Datum: 11.05.2012 - 07:02 Uhr
Sprache: Deutsch
News-ID 145410
Anzahl Zeichen: 6159
contact information:
Town:
Lysaker
Kategorie:
Business News
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