Canaccord Genuity on Life Sciences/Biotechnology: FDA �Flexibility� May Add To Advantages of Orphan Drugs in Today's Market
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Today's Overall Ratings:
Up: 8 | Down: 5 | New: 26
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Canaccord Genuity on Life Sciences/Biotechnology: FDA ‘Flexibility’ May Add To Advantages of Orphan Drugs in Today's Market
New NORD paper attempts to highlight FDA flexibility when evaluating efficacy of orphan drugs like lomitapide (Nasdaq: AEGR), Amigal (Nasdaq: FOLD), taliglucerase (NYSE: PLX), and RP103 (Nasdaq: RPTP)
Canaccord analyst, Ritu Baral, said, "We think NORD analysis underscores trends and initiatives toward less rigid, burdensome reviews, which may add to investment advantages that orphan drug companies have in today’s biotech landscape. An article published last week by the National Organization for Rare Disorders (NORD) discusses legislation that allows for expedited development and regulatory review of orphan drug candidates as well as laws that enable FDA flexibility and discretion in evaluating the risks and benefits of orphan drugs. While the paper is essentially a success analysis of FDA practice, we note that the discussion surrounding it in the agency and rare disease community underscores the near-universal pressure on FDA to responsibly enable more orphan disease drug development and approvals. This is in direct contrast to conventional drugs, which are experiencing increased agency scrutiny on approval standards."
"We already see orphan drug sales as relatively immune to utilization issues seen with other drugs in a weak economy...We also think orphan drugs enjoy relative price inelasticity, bucking the general healthcare trend of pricing pressure."
"We believe orphan drug advantages are relevant to lead drugs of coverage companies Aegerion (AEGR), Amicus (FOLD), Raptor (RPTP) and Protalix (PLX). We think the NORD piece gives precedent for FDA flexibility when evaluating the lead drugs of several of our coverage companies: Aegerion (lomitapide for HoFH), Amicus (Amigal for Fabry disease), Protalix (taliglucerase for Gaucher disease), and Raptor (RP103 for cystinosis)."
New NORD paper attempts to highlight FDA flexibility when evaluating efficacy of orphan drugs like lomitapide (Nasdaq: AEGR), Amigal (Nasdaq: FOLD), taliglucerase (NYSE: PLX), and RP103 (Nasdaq: RPTP)
Canaccord analyst, Ritu Baral, said, "We think NORD analysis underscores trends and initiatives toward less rigid, burdensome reviews, which may add to investment advantages that orphan drug companies have in today’s biotech landscape. An article published last week by the National Organization for Rare Disorders (NORD) discusses legislation that allows for expedited development and regulatory review of orphan drug candidates as well as laws that enable FDA flexibility and discretion in evaluating the risks and benefits of orphan drugs. While the paper is essentially a success analysis of FDA practice, we note that the discussion surrounding it in the agency and rare disease community underscores the near-universal pressure on FDA to responsibly enable more orphan disease drug development and approvals. This is in direct contrast to conventional drugs, which are experiencing increased agency scrutiny on approval standards."
"We already see orphan drug sales as relatively immune to utilization issues seen with other drugs in a weak economy...We also think orphan drugs enjoy relative price inelasticity, bucking the general healthcare trend of pricing pressure."
"We believe orphan drug advantages are relevant to lead drugs of coverage companies Aegerion (AEGR), Amicus (FOLD), Raptor (RPTP) and Protalix (PLX). We think the NORD piece gives precedent for FDA flexibility when evaluating the lead drugs of several of our coverage companies: Aegerion (lomitapide for HoFH), Amicus (Amigal for Fabry disease), Protalix (taliglucerase for Gaucher disease), and Raptor (RP103 for cystinosis)."
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