This is free marketing research on the Iclaprim Research industry and can include information on the background, market structure, definitions, competitors, trends and developments of Iclaprim research and is related to other topics such as drugs and medicine.

Iclaprim trial results: Good, but good enough?

Arpida has announced positive phase III trial for iclaprim, but Datamonitor asserts that Arpida will need to work hard in order to attract the partner it will require to realize the drug's commercial potential in this increasingly saturated market sector.

Arpida's ASSIST-2 (Arpida's Skin and Skin Structure Infection STudies) trial successfully met its primary endpoint, namely non-inferiority in clinical cure rates versus Pfizer's Zyvox (linezolid), confirming results of ASSIST-1, an earlier phase III trial. On the basis of these results, Arpida anticipates being able to file the drug for approval in the US by the end of the year.

Barriers to market penetration remain

The trial design is in line with the majority of those targeting the market for serious bacterial infections. The use of an indication such as cSSSI for approval is intended to increase the number of prescribing decisions in which iclaprim can be considered as a potential therapy. Meanwhile, its coverage of MRSA is intended to boost confidence in the drug's ability to deal with increasing levels of Gram positive infections that do not respond to older, more conventional products.

However, Arpida will face substantial barriers to achieving meaningful market penetration. Firstly, Arpida needs to clearly promote its product's suitability for the market. Iclaprim is not an entirely novel product: It is derived from the same class as the heavily exploited drug trimethoprim. Trimethoprim's use is dropping due to its weak bactericidal activity and propensity for resistance. Iclaprim has shown itself to be able to mostly side-step the issue of widespread trimethoprim resistance, and demonstrated improvements in terms of activity against a broader array of pathogens. Nevertheless, these advances are likely to be scrutinized heavily due to the drug's class heritage and they will need to be persistently reinforced throughout the drug's lifecycle.

This task would be easier had it not been for the commercial landscape in which iclaprim will be competing. Over recent years mounting concerns have arisen around antibiotic resistance. Gram negative bacteria in particular have generated increasing levels of resistance to conventional antibiotics, and MRSA has been at the center of clinical and public debate. The costs associated with treatment failure in these infections have provided a relatively rare opportunity for drug developers in the antibiotic market, which is generally characterized by high volumes of cheap products, many of which are generic.

Strong commercial support required

Accordingly, iclaprim will be entering a market which is currently occupied by a number of large, established products, as well as a wave of new products set to launch with the backing of highly experienced and well-resourced pharmaceutical companies. For example, while the trials used Pfizer's Zyvox as a comparator, there are a number of other competitors that Arpida needs to consider, such as AstraZeneca's Merrem (meropenem), generic vancomycin and Cubist and Novartis' Cubicin (daptomycin).

Additionally, iclaprim will face competition from Pfizer's Zeven (dalbavancin), Astellas' Arbelic (telavancin), Targanta's oritavancin, Forest and Takeda's ceftaroline and Basilea and Johnson & Johnson's ceftobiprole. The vast majority of these companies have also focused on the Gram positive spectrum of problematic infections (and MRSA in particular), and on cSSSIs and/or serious respiratory tract infections.

Datamonitor expects that due to this level of saturation, even the most promising brands with the most comprehensive sales and marketing back-up will struggle to meet their owners' high revenue expectations. Arpida, on the other hand, has not yet discussed any official interest from potential marketing partners for its product.

Strategies for success

Arpida's current need is therefore to attract a partner that has the ability to create the space in sales and marketing coverage from competing products to demonstrate iclaprim's potential. To this end, its latest trial results are good news for Arpida, but alone are likely to be insufficient to attract a partner prepared to take on what is rapidly becoming a saturated market space.

In order to achieve this, Datamonitor believes that Arpida needs to outline plans for four aspects of the drug that showcase some specific capabilities that demonstrate iclaprim to be a long term investment aligned to the future shape of the market.

Firstly, in order to reflect the shortfalls in antibiotic coverage following the wave of forthcoming new launches, iclaprim's potential against Gram negative pathogens needs to be fully exploited. This will potentially lead Arpida into direct competition with Wyeth's Tygacil (tigecycline), but nonetheless, a portion of the market that Datamonitor believes will be an important driver of unmet needs over the forthcoming years. Asides from Tygacil, and perhaps ceftobiprole, physicians have very few options left for the management of infections caused by problematic Gram negative pathogens: if resistance to the carbapenems emerges, alternatives are limited.

Secondly, Arpida needs to showcase the drug's potential in one of a number of indications which have been largely neglected in recent years, but demonstrate high unmet need. Arpida is likely to seek approval in hospital acquired pneumonia; depending on iclaprim's specific tissue penetration capabilities these might include bacteremia, endocarditis, obstetric infections, osteomyelitis or prosthetics infections.

Thirdly, Arpida needs to be assertive about the potential for its oral formulation of iclaprim, facilitating the intravenous to oral switch that enables shorter hospital stays and the use outside the hospital market.

Lastly, Arpida needs to moderate any concerns that potential outsiders will have about licensing or subsidizing a new product destined for the antibiotics market, and regulatory scrutiny is likely to be high on the list. With the backdrop of a number of product withdrawals over recent years, the FDA has become increasingly demanding regarding safety, clinical trial structure and data requirements. Demonstration of close liaisons throughout clinical trial processes will be essential to bolster confidence amongst potential partners.

Arpida: not alone

Arpida's trial results are encouraging, and iclaprim's membership of an underpopulated class and oral formulation potential may hold it in good stead. However, Datamonitor believes that with so much focus on the Gram positive side of the serious bacterial infections market, even well funded and supported late stage pipeline products are going to struggle to achieve their true commercial perspective. If this is true for products like Cubicin and Zeven, with the backing of Novartis and Pfizer, then the marketers of products like oritavancin (Targanta), ceftaroline (Forest/Takeda) will experience even higher barriers to the success they might have enjoyed in a less saturated market.

Related research:

• Stakeholder Opinions: Nosocomial Infections - The need for new gram-negative drugs

• Commercial Insight: Antibacterials - Growth in resistance rates drives niche indications

• Stakeholder Insight: Respiratory Tract Infections in the USA - The demise of narrow-spectrum antibiotics