SMALL CAP SHARE IDEAS: German healthcare provider Biofrontera looks to the US to 拡大する its sun-induced 肌 癌 治療

By Ian Lyall, Proactive 投資家s

Updated: 18:25 BST, 21 July 2014

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Rarely does a fledgling healthcare company take its 治療 権利 through the 研究 and 開発 段階 and の上に the market.

But this is 正確に／まさに what dermatology specialist Biofrontera has done in Europe with Ameluz, its sun-induced 肌 癌 治療.

There are 計画（する）s to go at least one 行う／開催する／段階 その上の with Ameluz by taking it to the US.

Su n 損失: Dermatology specialist Biofrontera hopes to take its sun-induced 肌 癌 治療 to the US

And it is also working on an 指示，表示する物 for 製品 that will 取り組む basal 独房 carcinoma - or BCC - a more difficult-to-扱う／治療する 肌 癌.

'Biofrontera is a member of a very 排除的 club: a small European 麻薬 開発 company with an 認可するd 製品 which it has developed and 開始する，打ち上げるd itself,' said Keith Redpath, 分析家 at the growth company specialist finnCap.

名簿（に載せる）／表（にあげる）d in Frankfurt, Biofrontera （機の）カム to AIM last month with a market capitalisation of ?61million. A ?15.3million fundraise in Germany earlier this year means it is 井戸／弁護士席 基金d.

In Ameluz it has developed a best-in-class 製品 that 取り組むs actinic keratosis - or AK - a very ありふれた pre-cancerous 肌 lesion.

It is a topical 製品 that is 活動させる／戦時編成するd using a lamp.

Up until recently it was thought these scaly plaques, 設立する around the 長，率いる, ears and nose, were 害のない.

And the 手続きs to 除去する them, which 含むd 氷点の them off, were considered cosmetic.

However, 研究 has 明らかにする／漏らすd AK can lead to squamous 独房 carcinoma, a 潜在的に 致命的な, 非，不，無-melanoma form of 肌 癌.

There are two 臨床の 裁判，公判s in Europe to 拡大する the use of, and 指示，表示する物 for Ameluz.

One will 決定する efficacy in BCC, while the other will 診察する ‘whole area 治療’ for AK. 現在／一般に Ameluz, like its 競争相手 Metvix, is 適用するd only to the lesion.

Biofrontera must make a regulatory submission to the US Food & 麻薬 行政 before it can begin selling Ameluz in the 明言する／公表するs.

The data is 推定する／予想するd to be 手渡すd to the regulator in the first ４半期/4分の1 of 2015, so the American 開始する，打ち上げる of Ameluz looks likely to occur in 早期に 2016.

'普通の／平均（する） 是認 time with FDA is 現在／一般に 10 months,' said 長，指導者 (n)役員／(a)執行力のある and 創立者, Professor Hermann L?bbert.

'As we have very strong 臨床の data we think we won’t be much longer than this. In our own 計算／見積りs we always come up with 12 months.'

Of course, in Europe Ameluz is already on sale. Biofrontera has 配当 協定s in 11 countries, although it 持続するs 支配（する）／統制する of the 製造業の.

The market for Ameluz for AK and BCC 麻薬s could be やめる 重要な, によれば 研究 that 示唆するs the former could be 価値（がある） US$941million 毎年 by 2020.

However, the more 早い growth is 推定する／予想するd to be seen in the BCC space, where sales are 推定する／予想するd to モーター from US$344million this year to just under US$5billion in six years.

'It has been a 比較して small but growing market and is 推定する／予想するd to grow much larger,' said L?bbert.

The 可能性のある of Ameluz is seen in the 研究 carried out by the small-cap 仲買人 finnCap, which 見積（る）s the 製品 has gone from a standing start to 60 per cent 株 in its home market segment in Germany in いっそう少なく than 12 months.

'We believe that, given the proven superior efficacy to 現職の 製品s, a 類似の profile of market 侵入／浸透 could be 達成するd in other 領土s,' said 分析家 Redpath.

'[It] is 早期に in the 開始する，打ち上げる 段階 in countries where distributors have been 任命するd, so we 推定する／予想する to see 重要な 歳入 growth over the next few years.'

Redpath recently 始めるd ニュース報道 of the 在庫／株 with a ?5.40 a 株 price 的 ? which is around 二塁打 現在の 株 price. He is 予報するing the group reaches profitability next year.

The kickers thereafter would be the US 開始する，打ち上げる, and the 拡大 of the 指示，表示する物 to cover BCC.

The 可能性のある payback on an 概算の ?80million spent developing Ameluz vindicates L?bbert’s 決定／判定勝ち（する） not to partner the 製品 and go it alone through the regulatory 過程.

It does have 利益／興味 from Maruho, the Japanese dermatology-焦点（を合わせる）d 製薬の company that has a 20.1 per cent 火刑／賭ける and which subscribed to the last two 基金ing 一連の会議、交渉／完成するs.

However, it appears the Japanese 会社／堅い is more 利益／興味d in 存在 a 協力者 than a 可能性のある acquirer of Biofrontera.

In the 合間, there is a 重要な 適切な時期 for 投資家s, if the finnCap 分析 and 株 price 的 証明するs 訂正する.